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.
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.
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 :
Inclusion Criteria:
ambulatory women,postmenopausal >= 5 years
have lumbar spine baseline BMD within the following criterion :
be in general good health as determined by medical history, physical examination and laboratory tests
Exclusion Criteria:
serum 25-OH vitamin D level <= 12 ng/ml
history of osteomalacia
history of active hyperparathyroidism or hyperthyroidism
hypocalcemia or hypercalcemia from any cause
depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
use of Vitamin D supplementation within 3 months prior to starting the investigational product
use of any of the following medications within a specified number of months prior to starting the investigational product :
any allergic or abnormal reaction to bisphosphonates
creatinine clearance < 30 ml/min