Risedronate in Postmenopausal Women With Low Bone Density
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
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.