A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy
- Conditions
- Postmenopausal Osteoporosis10005959
- Registration Number
- NL-OMON38276
- Lead Sponsor
- Amgen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 98
1. Ambulatory, postmenopausal women (based) on medical history) aged 55 years or older at screening :
-postmenopause will be defined as no vaginal bleeding or spotting for a least 12 months
2. received at least 1 prescription of oral alendronate therapy (weekly or dialy) as a first treatment for post menopausal osteoporosis in the 18 months prior to screening. Use of raloxifene, calcitonin or HRT prior to alendronate treatment will be allowed. Prior and/or current use of vitamin D and calcium will be allowed.
3,Subject has demonstrated 1 of the following :
-has stopped oral alendronate therapy (is denoted as non-persistent) at least one month before the screening visit
-is still taking oral alendronate therapy but demonstrates low adherence to therapy assessed by a score of less than 6 on the Osteoporosis Specific Morisky Medication Adherence Scale(OS-MMAS)
4.Provide signed informed consent before any study-specific procedures are conducted
1. any prior or current use of medications prescribed for osteoporosis treatment other than: oral daily or weekly alendronate, calcium and vitamin D
prior use of raloxifene, calcitonin or HRT before alendronate therapy was initiated will be allowed. Use of these therapies must have stopped prior to initiating oral alendronate and their current use is not allowed.;Any prior or current use of medications prescribed for osteoporosis treatment other than:
-oral daily or weekly alendronate, calcium and vitamin D
prior use of raloxifene, calcitonin, or HRT before alendronate therapy was initiated will be allowed. Use of these therapies must have stopped prior to initiating oral alendronate and their currentn use is not allowed
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of the study is to evaluate the effect of denosumab 60mg<br /><br>every 6 months (Q6M) compared with Actonel 150mg monthly (QM) on total hip Bone<br /><br>Mineral Density (BMD) at 12 months in postmenopausal women transitioning from<br /><br>previous alendronate therapy</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the effect of denosumab 60mg Q6M en Actonel 150 mg QM on CTX (<br /><br>C-terminal telopeptide) , a subset of subjects, at 1 month . Further to<br /><br>evaluateBMD at the femoral neck at 12 months and the BMD at the lumbar spine at<br /><br>12 months.<br /><br><br /><br>And to evaluate safety objectives as the effect and tolerability of denosumab<br /><br>60mg Q6M and Actonel 150 mg QM , measured by evaluating adverse events and<br /><br>laboratory parameters over 12 months.</p><br>