Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00343252

First received: June 20, 2006

Last updated: May 20, 2011

Last verified: May 2011

History of Changes

Results First Received: June 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Osteoporosis, Postmenopausal Back Pain Spinal Fracture
Interventions:	Drug: teriparatide Drug: risedronate Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
712 participants were randomized: 361 to teriparatide; 351 to risedronate. 2 participants did not receive drug. Only randomized participants who received at least 1 dose of drug were analyzed. At 18 months, reason for discontinuation was corrected from sponsor decision to entry criteria not met (1) and protocol violation (1) for 2 participants.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Participant Flow for 4 periods

Period 1: All Randomized Participants

	Teriparatide	Risedronate
STARTED	361	351
COMPLETED	259	269
NOT COMPLETED	102	82

Period 2: 6 Months (All Treated Participants)

	Teriparatide	Risedronate
STARTED	360 ^[1]	350 ^[2]
COMPLETED	304	306
NOT COMPLETED	56	44
Adverse Event	17	11
Death	0	2
Entry Criteria Not Met	10	8
Lack of Efficacy	0	1
Lost to Follow-up	0	4
Physician Decision	1	3
Protocol Violation	2	2
Sponsor Decision	7	4
Withdrawal by Subject	19	9

[1]	361 participants were randomized but 1 did not receive study drug and was not analyzed.
[2]	351 participants were randomized but 1 did not receive study drug and was not analyzed.

Period 3: 12 Months (All Treated Participants)

	Teriparatide	Risedronate
STARTED	360 ^[1]	350 ^[2]
COMPLETED	274 ^[3]	281 ^[3]
NOT COMPLETED	86	69
Adverse Event	22	20
Death	3	3
Entry Criteria Not Met	10	10
Lack of Efficacy	1	1
Lost to Follow-up	1	5
Physician Decision	4	5
Protocol Violation	3	2
Sponsor Decision	9	6
Withdrawal by Subject	33	17

[1]	361 participants were randomized but 1 did not receive study drug and was not analyzed.
[2]	351 participants were randomized but 1 did not receive study drug and was not analyzed.
[3]	Completed 12 Months.

Period 4: 18 Months (All Treated Participants)

	Teriparatide	Risedronate
STARTED	360	350
COMPLETED	259	269
NOT COMPLETED	101	81
Adverse Event	31	23
Death	4	5
Entry Criteria Not Met	11	10
Lack of Efficacy	1	1
Lost to Follow-up	3	7
Physician Decision	4	7
Protocol Violation	3	3
Sponsor Decision	8	5
Withdrawal by Subject	36	20

Baseline Characteristics

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Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
Total	Total of all reporting groups

Baseline Measures

	Teriparatide	Risedronate	Total
Number of Participants [units: participants]	360	350	710
Age [units: years] Mean ± Standard Deviation	70.54 ± 8.80	71.55 ± 8.12	71.04 ± 8.48
Gender [units: participants]
Female	360	350	710
Male	0	0	0
Race/Ethnicity, Customized [units: participants]
Hispanic	67	61	128
African Descent	2	3	5
Caucasian	285	286	571
East Asian	3	0	3
Native American	3	0	3
Region of Enrollment [units: participants]
United States	50	48	98
Argentina	38	42	80
Australia	30	30	60
Belgium	7	6	13
Brazil	30	30	60
Canada	54	55	109
France	13	10	23
Italy	22	20	42
Mexico	23	23	46
Puerto Rico	12	10	22
Spain	32	32	64
Sweden	13	10	23
Germany	36	34	70
Number of Vertebral Fractures ^[1] [units: participants]
Unknown or No Vertebral Fractures	37	35	72
1 Vertebral Fracture	126	104	230
>=2 Vertebral Fractures	197	211	408
Prior Osteoporosis Drug Use ^[2] [units: participants]
Yes	267	258	525
No	93	92	185
Severity of Vertebral Fracture ^[3] [units: participants]
Zero or Mild Severity (Grade 0)	50	46	96
Moderate Severity (Grade 2)	160	166	326
Severe (Grade 3)	142	131	273
Unknown or Not Reported	8	7	15
Spinal Deformity Index ^[4] [units: units on a scale]
0	29	28	57
1	11	16	27
2	76	67	143
>=3	236	232	468
Unknown or Not Reported	8	7	15
24-Hour Average Back Pain Score ^[5] [units: units on a scale] Mean ± Standard Deviation	5.34 ± 1.86	5.40 ± 1.85	5.37 ± 1.85
24-Hour Worst Back Pain Score ^[6] [units: units on a scale] Mean ± Standard Deviation	6.80 ± 1.63	6.91 ± 1.54	6.85 ± 1.59
Body Mass Index ^[7] [units: kilograms/meters squared] Mean ± Standard Deviation	26.30 ± 5.01	26.36 ± 4.91	26.33 ± 4.96
Duration of Back Pain [units: days] Mean ± Standard Deviation	550.33 ± 918.18	550.88 ± 750.47	550.58 ± 842.78
Height [units: centimeters] Mean ± Standard Deviation	154.82 ± 7.41	153.62 ± 7.86	154.23 ± 7.66
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) Score ^[8] [units: units on a scale] Mean ± Standard Deviation	47.08 ± 14.61	46.98 ± 14.39	47.03 ± 14.49
Roland-Morris Disability Questionnaire Score ^[9] [units: units on a scale] Mean ± Standard Deviation	11.88 ± 5.47	12.12 ± 5.40	12.00 ± 5.44
Weight [units: kilograms] Mean ± Standard Deviation	63.02 ± 12.70	62.27 ± 12.58	62.65 ± 12.63

[1]	A minimum of at least one moderate osteoporotic vertebral fracture was radiologically detected and vertebral fracture status was documented. A moderate vertebral fracture was defined as at least a 25% decrease in anterior, central, or posterior vertebral height (T4 to L4) as compared to the average height of adjacent vertebrae. This measure categorizes the number of vertebral fractures for each participant.
[2]	Participants answered yes or no regarding use of osteoporosis drugs prior to this study.
[3]	An experienced radiologist graded all vertebrae by visual inspection from normal (grade 0) to severely deformed (grade 3).
[4]	Spinal deformity index is the summation of the severity of the vertebral fracture(s).
[5]	24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the specified last observation carried forward (LOCF) endpoint.
[6]	24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
[7]	Body mass index is an estimate of body fat based on body weight divided by height squared.
[8]	QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
[9]	Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked is added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).

Outcome Measures

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1. Primary:

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint [ Time Frame: 6 Months ]

Measure Type	Primary
Measure Title	Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint
Measure Description	24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Time Frame	6 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	348	336
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint [units: participants]
Responder to Treatment	206	193
Non-Responder to Treatment	142	143

Statistical Analysis 1 for Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint

Groups ^[1]	All groups
Method ^[2]	Chi-square
P Value ^[3]	0.642

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline to the 6-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	All comparisons were conducted using a 2-sided significance level of 0.05.

2. Secondary:

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint [ Time Frame: 12 Months ]

Measure Type	Secondary
Measure Title	Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint
Measure Description	24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Time Frame	12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	348	336
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint [units: participants]
Responder to Treatment	233	220
Non-Responder to Treatment	115	116

Statistical Analysis 1 for Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint

Groups ^[1]	All groups
Method ^[2]	Chi-square
P Value ^[3]	0.683

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of worst back pain from baseline at the 12-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	All comparisons were conducted using a 2-sided significance level of 0.05.

3. Secondary:

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint [ Time Frame: 6 Months ]

Measure Type	Secondary
Measure Title	Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint
Measure Description	24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month last observation carried forward (LOCF) endpoint.
Time Frame	6 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	347	336
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint [units: participants]
Responder to Treatment	221	211
Non-Responder to Treatment	126	125

Statistical Analysis 1 for Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint

Groups ^[1]	All groups
Method ^[2]	Chi-square
P Value ^[3]	0.809

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 6-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	All comparisons were conducted using a 2-sided significance level of 0.05.

4. Secondary:

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint [ Time Frame: 12 Months ]

Measure Type	Secondary
Measure Title	Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint
Measure Description	24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month last observation carried forward (LOCF) endpoint.
Time Frame	12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	347	336
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint [units: participants]
Responder to Treatment	246	238
Non-Responder to Treatment	101	98

Statistical Analysis 1 for Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint

Groups ^[1]	All groups
Method ^[2]	Chi-square
P Value ^[3]	0.986

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with at least a 30% reduction in the severity of average back pain from baseline to the 12-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	All comparisons were conducted using a 2-sided significance level of 0.05.

5. Secondary:

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months [ Time Frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300 ]

Measure Type	Secondary
Measure Title	Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months
Measure Description	Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 6 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time Frame	Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	348	336
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months [units: participants]
Day 0	0	0
Day 30	26	22
Day 60	70	74
Day 90	110	111
Day 120	151	145
Day 150	175	164
Day 180	195	181
Day 210	206	192
Day 240	206	193
Day 270	206	193
Day 300	206	193

Statistical Analysis 1 for Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.746
Hazard Ratio (HR) ^[4]	1.03
95% Confidence Interval	( 0.85 to 1.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in worst back pain at the 6-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
[4]	Other relevant estimation information:
	No text entered.

6. Secondary:

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months [ Time Frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 ]

Measure Type	Secondary
Measure Title	Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months
Measure Description	Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 12 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time Frame	Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	348	336
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months [units: participants]
Day 0	0	0
Day 60	70	74
Day 120	151	145
Day 180	195	181
Day 240	206	193
Day 300	224	206
Day 360	226	209
Day 420	233	220
Day 480	233	220
Day 540	233	220
Day 600	233	220

Statistical Analysis 1 for Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.719
Hazard Ratio (HR) ^[4]	1.03
95% Confidence Interval	( 0.86 to 1.25 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in worst back pain at the 12-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
[4]	Other relevant estimation information:
	No text entered.

7. Secondary:

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months [ Time Frame: Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300 ]

Measure Type	Secondary
Measure Title	Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months
Measure Description	Time to first occurrence of >=30% pain reduction in average back pain from baseline to 6 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time Frame	Days 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, and 300
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed. The results are reported as the number of participants reporting at least a 30% reduction in the severity of back pain after time (t) in days.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	347	336
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months [units: participants]
Day 0	0	0
Day 30	40	33
Day 60	91	86
Day 90	136	130
Day 120	175	162
Day 150	199	178
Day 180	212	200
Day 210	221	210
Day 240	221	211
Day 270	221	211
Day 300	221	211

Statistical Analysis 1 for Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.681
Hazard Ratio (HR) ^[4]	1.04
95% Confidence Interval	( 0.86 to 1.26 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction for average back pain at the 6-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
[4]	Other relevant estimation information:
	No text entered.

8. Secondary:

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months [ Time Frame: Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600 ]

Measure Type	Secondary
Measure Title	Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months
Measure Description	Time to first occurrence of >= 30% pain reduction in average back pain from baseline to 12 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time Frame	Days 0, 60, 120, 180, 240, 300, 360, 420, 480, 540, and 600
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	347	336
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months [units: participants]
Day 0	0	0
Day 60	91	86
Day 120	175	162
Day 180	212	200
Day 240	221	211
Day 300	234	220
Day 360	238	226
Day 420	246	238
Day 480	246	238
Day 540	246	238
Day 600	246	238

Statistical Analysis 1 for Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.789
Hazard Ratio (HR) ^[4]	1.02
95% Confidence Interval	( 0.86 to 1.23 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the time to first occurrence of a >=30% reduction in average back pain at the 12-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No adjustments for multiplicity were performed.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparison of the Kaplan-Meier survival curves between treatment groups was conducted using log-rank, significance level of 0.05.
[4]	Other relevant estimation information:
	No text entered.

9. Secondary:

Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 3 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.
Measure Description	Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame	Baseline, 3 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	334	311
Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. [units: units on a scale] Least Squares Mean ± Standard Error	-1.42 ± 0.45	-1.41 ± 0.45

Statistical Analysis 1 for Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.968

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between the treatment groups in the proportion of participants with a reduction in disability at the 3-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiplicity were performed.

10. Secondary:

Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 6 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.
Measure Description	Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame	Baseline, 6 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	341	319
Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. [units: units on a scale] Least Squares Mean ± Standard Error	-1.58 ± 0.48	-1.77 ± 0.48

Statistical Analysis 1 for Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.568

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 6-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiplicity were performed.

11. Secondary:

Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 12 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.
Measure Description	Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
Time Frame	Baseline, 12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	343	322
Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. [units: units on a scale] Least Squares Mean ± Standard Error	-2.09 ± 0.54	-2.12 ± 0.53

Statistical Analysis 1 for Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.932

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with a reduction in disability at the 12-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiplicity were performed.

12. Secondary:

Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [ Time Frame: Baseline, 6 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Measure Description	QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time Frame	Baseline, 6 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	344	326
Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [units: units on a scale] Least Squares Mean ± Standard Error	-2.80 ± 1.11	-2.63 ± 1.10

Statistical Analysis 1 for Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.814

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 6-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiplicity were performed.

13. Secondary:

Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [ Time Frame: Baseline, 12 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Measure Description	QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time Frame	Baseline, 12 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of intent-to-treat (ITT) participants who were randomized and received at least one dose of the study drug. Endpoint was on a last observation carried forward (LOCF) basis. Participants with non-missing outcomes were analyzed.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	344	327
Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [units: units on a scale] Least Squares Mean ± Standard Error	-5.74 ± 1.23	-5.27 ± 1.22

Statistical Analysis 1 for Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.572

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Tested the null hypothesis that there is no statistically significant difference between treatment groups in the proportion of participants with an improvement in quality of life at the 12-month endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	The model includes terms for treatment, pooled site, baseline glucocorticoid usage status (yes/no), and baseline score.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No adjustments for multiplicity were performed.

14. Secondary:

Number of Participants With Adverse Events (Safety) During 12 Months [ Time Frame: Baseline through 12 Months ]

Measure Type	Secondary
Measure Title	Number of Participants With Adverse Events (Safety) During 12 Months
Measure Description	Safety was assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Time Frame	Baseline through 12 Months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	360	350
Number of Participants With Adverse Events (Safety) During 12 Months [units: participants]
Serious Adverse Events	39	50
Adverse Events	269	266

No statistical analysis provided for Number of Participants With Adverse Events (Safety) During 12 Months

15. Secondary:

Number of Participants With Adverse Events (Safety) During 18 Months [ Time Frame: Baseline through 18 Months ]

Measure Type	Secondary
Measure Title	Number of Participants With Adverse Events (Safety) During 18 Months
Measure Description	Safety is assessed via serious adverse events and all other non-serious adverse events and the data are located in the Reported Adverse Events Section.
Time Frame	Baseline through 18 Months
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT). ITT participants are randomized participants who received at least one dose of teriparatide or risedronate.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	360	350
Number of Participants With Adverse Events (Safety) During 18 Months [units: participants]
Serious Adverse Events	55	66
Adverse Events	277	273

No statistical analysis provided for Number of Participants With Adverse Events (Safety) During 18 Months

16. Secondary:

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint [ Time Frame: 18 Months ]

Measure Type	Secondary
Measure Title	Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint
Measure Description	24-hour worst back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of worst back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of worst back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Time Frame	18 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT). Participants are participants who were randomized and received at least one dose of the study drug.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	360	349
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint [units: participants]
Responder	248	234
Non-Responder	112	115

Statistical Analysis 1 for Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.600

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value is for responder versus non-responder.

17. Secondary:

Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint [ Time Frame: 18 Months ]

Measure Type	Secondary
Measure Title	Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint
Measure Description	24-hour average back pain severity scores recorded daily on an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). The 11-point scale is used for assessment of average back pain in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. Responders are defined as participants with at least a 30% reduction in the severity of average back pain from baseline to the 18-month last observation carried forward (LOCF) endpoint.
Time Frame	18 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT). ITT participants were participants who randomized and received at least one dose of the study drug.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	360	349
Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint [units: participants]
Responder	260	242
Non-responder	100	107

Statistical Analysis 1 for Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.399

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value is for responder versus non-responder.

18. Secondary:

Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months [ Time Frame: Baseline through 18 Months ]

Measure Type	Secondary
Measure Title	Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months
Measure Description	Time to first occurrence of >= 30% pain reduction in worst back pain from baseline to 18 months. Worst back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the worst back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of worst back pain up to time (t) in days.
Time Frame	Baseline through 18 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis includes number of randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	360	349
Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months [units: participants]	248	234

Statistical Analysis 1 for Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.453
Hazard Ratio (HR) ^[4]	1.07
95% Confidence Interval	( 0.89 to 1.28 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

19. Secondary:

Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months [ Time Frame: Baseline through 18 Months ]

Measure Type	Secondary
Measure Title	Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months
Measure Description	Time to first occurrence of >=30% pain reduction in average back pain from baseline to 18 months. Average back pain is assessed using an 11-point numeric rating scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain), to rate the average back pain experienced in the preceding 24 hours and is evaluated daily in the week prior to each scheduled study visit. The results are reported as the number of participants reporting at least a 30% reduction in the severity of average back pain up to time (t) in days.
Time Frame	Baseline through 18 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized intent-to-treat (ITT) participants in each treatment group with non-missing time.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	360	349
Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months [units: participants]	260	242

Statistical Analysis 1 for Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months

Groups ^[1]	All groups
Method ^[2]	Log Rank
P Value ^[3]	0.353
Hazard Ratio (HR) ^[4]	1.09
95% Confidence Interval	( 0.91 to 1.30 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

20. Secondary:

Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. [ Time Frame: Baseline, 18 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.
Measure Description	Roland-Morris Disability Questionnaire (RMDQ-24) is completed by the participant and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the participant is instructed to put a mark next to each appropriate statement. The number of statements marked are added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability). Pooled site, baseline glucocorticoid usage status (yes/no) and baseline score were controlled for.
Time Frame	Baseline, 18 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	343	323
Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. [units: units on a scale] Least Squares Mean ± Standard Error	-3.21 ± 0.54	-3.19 ± 0.53

Statistical Analysis 1 for Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire.

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.943

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

21. Secondary:

Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [ Time Frame: Baseline, 18 Months ]

Measure Type	Secondary
Measure Title	Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)
Measure Description	QUALEFFO is an osteoporosis-specific health instrument developed specifically for participants with vertebral deformities used to evaluate the effect of back pain and treatment on quality of life. The QUALEFFO questionnaire includes 41 items in 5 domains: pain, physical function, social function, general health perception, and mental function. The total score is calculated according to the scoring algorithm developed by the International Osteoporosis Foundation. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Time Frame	Baseline, 18 Months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-treat (ITT). Participants who were randomized and received at least one dose of the study drug.

Reporting Groups

	Description
Teriparatide	Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
Risedronate	Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo

Measured Values

	Teriparatide	Risedronate
Number of Participants Analyzed [units: participants]	344	327
Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) [units: units on a scale] Least Squares Mean ± Standard Error	-5.67 ± 1.27	-5.17 ± 1.26

Statistical Analysis 1 for Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO)

Groups ^[1]	All groups
Method ^[2]	ANCOVA
P Value ^[3]	0.553

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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Serious Adverse Events

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00343252 History of Changes
Other Study ID Numbers:	9041, B3D-MC-GHCY
Study First Received:	June 20, 2006
Results First Received:	June 8, 2010
Last Updated:	May 20, 2011
Health Authority:	United States: Food and Drug Administration

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