Overview

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