A 2-year extension to study 2203, partially randomized, double-blind, placebo-controlled in the first year and open label in the second year, to assessthe safety of the dose of AAE581 selected for phase III development in postmenopausal osteoporosis, and the offset of effect on biomarkers and BMD - 2203E1
Phase 1
- Conditions
- Osteoporosis is a metabolic bone disease characterized by low bone mass and microarchitectural deterioration of bone tissue, leading to enhanced fragility and a consequent increase in fracture risk.
- Registration Number
- EUCTR2004-002952-33-ES
- Lead Sponsor
- ovartis Farmaceútica S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
Inclusion Criteria
Any patient who completed the core study 2203.
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
The patients who were non-compliant or who demonstrated a major protocol violation in the core study and who developed any disease mentioned in the exclusion criteria of the core study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To obtain 3-year safety data of AAE581 for phase 3 program.<br>;Secondary Objective: To assess long-term efficacy of AAE581 on BMD by DXA on lumbar spine, total hip, total body, forearm and the effect on biomarkers over the 24 month extension period and over the entire 36 month period of the combined core and extension studies, and to obtain the offset of action over one year on biomarkers and BMD.;Primary end point(s): To obtain 3-year safety data of AAE581 for phase 3 program.
- Secondary Outcome Measures
Name Time Method