NCT00351091

Risedronate in Postmenopausal Women With Low Bone Density

a Six Month, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study to Estimate the Pharmacodynamic Response of Two Risedronate Regimens Compared With 5mg Daily : 150mg Monthly Dose for Six Months and 15mg Daily for Thirty Days Followed by 150mg Monthly Dose for 5 Months in Postmenopausal Women With Low Bone Density.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Sanofi · Industry
• Sex: Female
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months The secondary objectives are : * To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate. * To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate. * To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate. * To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.

Conditions

• OSTEOPOROSIS, POSTMENOPAUSAL

Interventions

Type	Name	Description
DRUG	RISEDRONATE

Timeline

• Start date: 2002-11-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2006-07-12
• Last updated: 2012-02-17