Study Complete
Sponsor ID
20060289
Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
Study Details
The primary objective was to describe the safety and tolerability of up to 10 years or
7 years denosumab administration as measured by adverse event monitoring,
immunogenicity and safety laboratory parameters in participants who previously received denosumab or placebo, respectively.
Protocol Summary
Primary Outcome Measures
To describe the safety and tolerability of up to 7 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab
Timeframe: 7 years
Secondary Outcome Measures
• To describe the effect of denosumab administration on changes in BMD
Timeframe: 7 years
• To describe the incidence of fractures
Timeframe: 7 years
• To describe the effect of denosumab administration on markers of bone turnover
Timeframe: 7 years
• To describe the change in safety labs
Timeframe: 7 years
• To describe the effect of up to 7 years denosumab administration on bone histology in subjects who previously received denosumab
Timeframe: 7 years
Study Documents
Study Synopsis
Available Language(s): English
Locations
No locations found.