Study Complete
Sponsor ID
20060289

Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis

Sponsor ID
20060289
Clinicaltrials.gov ID
NCT00523341
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
4550
Additional Study Details

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.