Risedronate in Postmenopausal Women With Low Bone Density

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Procter and Gamble
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• ambulatory women,postmenopausal >= 5 years

• have lumbar spine baseline BMD within the following criterion :

• Hologic: <= 0.827 g/cm2 or

• Lunar: <= 0.942 g/cm2 or

• Norland: <= 0.768 g/cm2

• 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 bisphosphonate.

• use of any fluoride with the exception of fluoride use for oral hygiene

• strontium

• other bone active agents

• subcutaneous estrogen implant

• oral or parenteral glucocorticoids

• anabolic steroids

• estrogen or estrogen-related drugs, except for low dose vaginal creams

• progestogen

• calcitonin, calcitriol, or calcifediol

• any allergic or abnormal reaction to bisphosphonates

• creatinine clearance < 30 ml/min