A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated with Daily or WeeklyBisphosphonates. - Denosumab 20080562
- Conditions
- Postmenopausal osteoporosisMedDRA version: 12.0Level: LLTClassification code 10031285Term: Osteoporosis postmenopausal
- Registration Number
- EUCTR2009-010726-19-IT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 800
Inclusion Criteria
Postmenopausal women with osteoporosis who have
received their first prescription of daily or weekly bisphosphonate therapy at least 6 months but no
more than 18 months prior to screening. In addition, eligible subjects will have discontinued
bisphosphonate treatment at least one month prior to screening or are still on treatment but have
insufficient adherence as measured by a score of less than 6 on the Osteoporosis Specific
Morisky Medication Adherence Scale (OS-MMAS).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
na
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method