Text Size

Phase 3 Clinical Trial of Teriparatide in Japan

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00433160
First received: February 7, 2007
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
Results First Received: August 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Osteoporosis
Interventions: Drug: Teriparatide
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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
Results from 4 patients aren't included in baseline and outcomes: 3 (2 placebo and 1 teriparatide) didn't receive study drug; 1 (placebo) had a significant good clinical practice issue of receiving study drug assigned to another patient.

Reporting Groups
  Description
Teriparatide 20 micrograms for 104 weeks
Placebo Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Participant Flow for 3 periods

 Period 1:   52-Week Double-Blind (DB) Period
    Teriparatide     Placebo  
STARTED     137     70  
Received Treatment     136     68  
COMPLETED     120     60  
NOT COMPLETED     17     10  
Adverse Event                 6                 2  
Death                 0                 0  
Lost to Follow-up                 0                 0  
Entry Criteria Exclusion                 0                 1  
Protocol Violation                 0                 2  
Withdrawal by Subject                 6                 1  
Physician Decision                 4                 2  
Sponsor Decision                 0                 0  
Lack of Efficacy                 1                 2  

Period 2:   76 Weeks, 24-Week Open Label (OL) Period
    Teriparatide     Placebo  
STARTED     119 [1]   59 [1]
Received Treatment     119     59  
COMPLETED     113     55  
NOT COMPLETED     6     4  
Adverse Event                 3                 1  
Withdrawal by Subject                 1                 2  
Physician Decision                 2                 0  
Lack of Efficacy                 0                 1  
[1] One participant did not continue to first OL period due to adverse event after completing DB period.

Period 3:   104 Weeks, 28-Week OL Period
    Teriparatide     Placebo  
STARTED     102 [1]   50 [2]
Received Treatment     102     50  
COMPLETED     92     47  
NOT COMPLETED     10     3  
Adverse Event                 2                 0  
Withdrawal by Subject                 8                 2  
Physician Decision                 0                 1  
[1] Eleven participants withdrew at end of first OL period and did not continue on to second OL period.
[2] Five participants withdrew at end of first OL period and did not continue on to second OL period.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Teriparatide 20 micrograms for 104 weeks
Placebo Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Total Total of all reporting groups

Baseline Measures
    Teriparatide     Placebo     Total  
Number of Participants  
[units: participants]
 		  136     67     203  
Age  
[units: years]
Mean ± Standard Deviation 		  69.2  ± 6.3     70.4  ± 5.4     69.6  ± 6.0  
Gender  
[units: participants]
 		     
Female     127     62     189  
Male     9     5     14  
Region of Enrollment  
[units: participants]
 		     
Japan     136     67     203  
Alcohol Consumption  
[units: participants]
 		     
No     99     51     150  
Yes     37     16     53  
Number of Previous Vertebral Fractures  
[units: participants]
 		     
0 Fractures     82     38     120  
1 Fracture     35     16     51  
2 Fractures     10     8     18  
3 Fractures     3     3     6  
4 Fractures     4     1     5  
5 or More Fractures     2     1     3  
Previous Osteoporosis Drug Use  
[units: participants]
 		     
No     86     44     130  
Yes     50     23     73  
Smoking History  
[units: participants]
 		     
Non-Smoker     114     53     167  
Past Smoker     6     9     15  
Current Smoker     16     5     21  
Body Mass Index [1]
[units: kilograms per square meter (kg/m^2)]
Mean ± Standard Deviation 		  21.58  ± 3.03     22.24  ± 3.34     21.80  ± 3.15  
Bone Mineral Density (BMD) Total Spine  
[units: grams per square centimeter (g/cm^2)]
Mean ± Standard Deviation 		  0.6153  ± 0.0701     0.6123  ± 0.0780     0.6143  ± 0.0726  
Height  
[units: centimeters (cm)]
Mean ± Standard Deviation 		  150.40  ± 5.97     150.30  ± 5.74     150.36  ± 5.89  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation 		  48.74  ± 6.83     50.25  ± 8.10     49.24  ± 7.29  
[1] Body mass index is an estimate of body fat based on body weight divided by height squared (kg/m^2).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)   [ Time Frame: Baseline to 52 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)   [ Time Frame: Baseline to 52 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   Percent Change in Bone Mineral Density (BMD) at Total Hip   [ Time Frame: Baseline to 52 Weeks ]
  Show Outcome Measure 3

4.  Secondary:   Percent Change in Bone Mineral Density (BMD) at Femoral Neck   [ Time Frame: Baseline to 52 Weeks ]
  Show Outcome Measure 4

5.  Secondary:   Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)   [ Time Frame: Baseline to Weeks 4, 12, 24, and 52 ]
  Show Outcome Measure 5

6.  Secondary:   Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)   [ Time Frame: Baseline to Weeks 4, 12, 24, 52 ]
  Show Outcome Measure 6

7.  Secondary:   Percent Change in Biochemical Markers of Bone Metabolism – Serum Type I Collagen Crosslinked C-telopeptide (CTX)   [ Time Frame: Baseline to Weeks 4, 12, 24, 52 ]
  Show Outcome Measure 7

8.  Secondary:   Vertebral Fractures by Central X-ray Assessment   [ Time Frame: Baseline through 52 weeks ]
  Show Outcome Measure 8

9.  Secondary:   Fractures by Investigators Assessment   [ Time Frame: Baseline through 52 Weeks ]
  Show Outcome Measure 9

10.  Secondary:   Back Pain Severity   [ Time Frame: Baseline, Weeks 12, 24, 36, 52 ]
  Show Outcome Measure 10

11.  Secondary:   Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 11

12.  Secondary:   Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 12

13.  Secondary:   Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 13

14.  Secondary:   Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 14

15.  Secondary:   Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 15

16.  Secondary:   Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 16

17.  Secondary:   Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 17

18.  Secondary:   Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks   [ Time Frame: Baseline through 104 Weeks ]
  Show Outcome Measure 18

19.  Secondary:   Fractures by Investigators Assessment During Entire Study Period of 104 Weeks   [ Time Frame: Baseline Through 104 Weeks ]
  Show Outcome Measure 19

20.  Secondary:   Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks   [ Time Frame: Baseline, 76 Weeks, 104 Weeks ]
  Show Outcome Measure 20


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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
Original data presented were for the 52-week double-blinded treatment phase; results of the open label phases at 76 weeks and 104 weeks have now been added  


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


Publications of Results:


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00433160     History of Changes
Other Study ID Numbers: 10494, B3D-JE-GHDB
Study First Received: February 7, 2007
Results First Received: August 17, 2009
Last Updated: September 14, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare