Drug Holidays in the Treatment With Alendronate in Postmenopausal Women With Osteoporosis
- Registration Number
- NCT00936260
- Lead Sponsor
- Ciudad Universitaria, Spain
- Brief Summary
The purpose of this study is to determine the duration of the treatment with alendronate in postmenopausal women with osteoporosis.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 228
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description alendronate 5 years alendronate No treatment during year 6th alendronate 6 years alendronate - alendronate 5 years, not continued alendronate No treatment during year 5th alendronate 4 years alendronate No treatment during year 5th and 6th alendronate 5 years, uncontinued alendronate No treatment during year 4th alendronate 4 years, not continued alendronate No treatment during year 4th and 6th alendronate 4 years, uncontinued alendronate No treatment during year 4th and 5th Alendronato 3 years alendronate No treatment during the last 3 years
- Primary Outcome Measures
Name Time Method Bone mineral density Every year
- Secondary Outcome Measures
Name Time Method Fractures Every year
Trial Locations
- Locations (1)
University San Carlos Hospital
🇪🇸Madrid, Spain