An observational, safety follow-up extension to studies 2203 and 2203E1 to assess the safety of AAE581 in postmenopausal women with osteopenia/osteoporosis
- Conditions
- Osteoporosis
- Registration Number
- EUCTR2007-002243-25-PL
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 675
Inclusion Criteria
• All patients randomized in the CAAE581A2203 core study
• Patients who have signed a written informed consent before any trial procedure is performed
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
• Patients who have taken any anti-osteoporosis therapy since study participation (core or extension E1)
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