Risedronate in Postmenopausal Women With Low Bone Density

Sanofi150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

OSTEOPOROSIS, POSTMENOPAUSAL

Eligibility

Sex: FEMALEMin age: 65 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Risedronate in Postmenopausal Women With Low Bone Density

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes