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

Status:	Completed
Conditions:	Osteoporosis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	55 - 80
Updated:	4/21/2016
Start Date:	August 2005
End Date:	August 2007

A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

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.

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)

We found this trial at

sites

GSK Investigational Site

Flint, Michigan 48504

824

from

Flint, MI