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Risedronate Dosing Regimens in Postmenopausal Women with Low Bone Density

NCT00351091Phase 2

Key facts

Status: Completed
Start: Nov 2002
Primary completion: Jun 2003
Sponsor: Sanofi
Modality: Small Molecules

Drugs: risedronate
Conditions: osteoporosis

Overview

Phase 2, randomised, double-blind trial of risedronate in osteoporosis (3 arms), sponsored by Sanofi. Primary endpoint: Urine N-telopeptide of type I collagen at 6 months. Started Nov 2002; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

5mg Daily
Risedronate 5mg daily for 6 months
150mg Monthly
Risedronate 150mg monthly for 6 months
Loading Dose Regimen
Risedronate 15mg daily for 30 days followed by 150mg monthly for 5 months

Who it enrols

Postmenopausal women (>= 5 years) with low lumbar spine bone density and general good health.

Endpoints

Primary

Urine N-telopeptide of type I collagen6 months

Secondary

Urine N-telopeptide of type I collagenother visits
Serum C-telopeptide of type I collagenall specified visits
Bone specific alkaline phosphataseall specified visits
Lumbar Spine Bone Mineral Density6 months
Safety evaluation

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