Study Complete
Sponsor ID
20080099

Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned from Alendronate therapy

Sponsor ID
20080099
Clinicaltrials.gov ID
NCT00919711
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
870
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage change from baseline in total hip bone mass density (BMD).

Timeframe: 12 months

Secondary Outcome Measures

Percent change from baseline in serum type 1 C-terminal telopeptide (CTX).

Timeframe: 1 month

Percent change from baseline in femoral neck BMD.

Timeframe: 12 months

Percent change from baseline in lumbar spine BMD.

Timeframe: 12 months

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.