A Study of Monthly Risedronate for Osteoporosis

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Warner Chilcott
• Collaborator: Sanofi
• Treatments: Etidronic Acid; Risedronate Sodium; Risedronic Acid

Criteria

Inclusion Criteria:

• Female: 50 years of age or older

• >5 years since last menses natural or surgical

• have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion Criteria:

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

• BMI (body mass index) >32 kg/m^2

• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone

• hypocalcemia or hypercalcemia of any cause

• markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator