A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Post-Menopausal Osteopenia

In brief

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00129623

Run by

Hoffmann-La Roche

People needed

160

Starts

2005-12-01

Expected to finish

2007-12-01

Last updated by the study team

2016-01-11

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• women 45-60 years of age;
• post-menopausal;
• ambulatory.

You may not qualify if…

• vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
• low-trauma osteoporotic fracture in any other bone;
• breast cancer diagnosed within last 20 years;
• other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
• treatment with any bisphosphonate within last 2 years;
• treatment with other drugs affecting bone metabolism within last 6 months.

Where it is running

• Study site — Lakewood, Colorado, United States
• Study site — Stuart, Florida, United States
• Study site — Bethesda, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Amarillo, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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