Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
This study has been completed.
Sponsor:
Ciudad Universitaria, Spain
Information provided by:
Ciudad Universitaria, Spain
ClinicalTrials.gov Identifier:
NCT00936260
First received: July 9, 2009
Last updated: NA
Last verified: January 1998
History: No changes posted
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Purpose
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Drug: alendronate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Alendronate sodium
U.S. FDA Resources
Further study details as provided by Ciudad Universitaria, Spain:
Primary Outcome Measures:
- Bone mineral density [ Time Frame: Every year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Fractures [ Time Frame: Every year ] [ Designated as safety issue: No ]
| Enrollment: | 228 |
| Study Start Date: | January 1998 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: alendronate 6 years |
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: alendronate 5 years
No treatment during year 6th
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: alendronate 5 years, not continued
No treatment during year 5th
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: alendronate 4 years
No treatment during year 5th and 6th
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: alendronate 5 years, uncontinued
No treatment during year 4th
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: alendronate 4 years, not continued
No treatment during year 4th and 6th
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: alendronate 4 years, uncontinued
No treatment during year 4th and 5th
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
|
Experimental: Alendronato 3 years
No treatment during the last 3 years
|
Drug: alendronate
several duration of treatment
Other Name: fosamax
|
Detailed Description:
The duration of the treatment with alendronate is not well established. The investigators recruited 228 women with postmenopausal osteoporosis. They all received alendronate during the first 3 years of monitoring and were later on randomized to whether different regimens of intermittent treatment or to carry on 3 years more.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- postmenopausal osteoporosis under densitometric criteria of the World Health Organization
Exclusion Criteria:
- secondary osteoporosis
- alteration in analytic parameters (total proteins, calcium, phosphorus, vitamin D, parathyroid hormone, thyroid hormone, transaminase, creatinine)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Esther Alvarez-Rodriguez, University San Carlos Hospital |
| ClinicalTrials.gov Identifier: | NCT00936260 History of Changes |
| Other Study ID Numbers: | individual reseacher |
| Study First Received: | July 9, 2009 |
| Last Updated: | July 9, 2009 |
| Health Authority: | Spain: Comité Ético de Investigación Clínica |
Keywords provided by Ciudad Universitaria, Spain:
|
osteoporosis postmenopausal alendronate |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Alendronate Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013