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

Completed · Phase 4 · Has a placebo group

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT00148915

Run by

Hoffmann-La Roche

People needed

98

Starts

2005-08-01

Expected to finish

2007-08-01

Last updated by the study team

2016-11-08

Who can join

Age: 55 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Boulder, Colorado, United States
• GSK Investigational Site — Lakewood, Colorado, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Decatur, Georgia, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Bangor, Maine, United States
• GSK Investigational Site — Bathesda, Maryland, United States
• GSK Investigational Site — Flint, Michigan, United States
• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — West Haverstraw, New York, United States
• GSK Investigational Site — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.