Overview

A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

Status:
Completed
Trial end date:
2007-08-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Diphosphonates
Ibandronic Acid
Criteria
Inclusion criteria:

- Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with
osteoporosis

- BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total
neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites

Exclusion criteria:

- Have been treated with other bisphosphonates or using chronic steroids within the past
6 months

- Have a history of major upper gastrointestinal (GI) diseases or have severe kidney
dysfunction

- Have a spine fracture (identified on X-ray)