A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)

Completed · Phase 4 · Has a placebo group

Conditions studied: Post Menopausal Osteoporosis

In brief

This study will determine the rapidity of suppression of the bone resorption marker sCTX in post-menopausal women with osteoporosis.Other bone turnover markers will also be evaluated. Patients will be randomised to either monthly Boniva 150mg or placebo, in combination with vitamin D and calcium supplementation. The anticipated time on study treatment is approximately 7 months, and the target sample size is \<100 individuals.

Key facts

Study ID

NCT00303485

Run by

Hoffmann-La Roche

People needed

67

Starts

2006-02-01

Expected to finish

2007-06-01

Last updated by the study team

2016-05-02

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• women who have been newly diagnosed with post-menopausal osteoporosis, requiring treatment;
• naive to bisphosphonate treatment,or had bisphosphonate treatment for a maximum of 3 months, at least 5 years before screening.

You may not qualify if…

• patients on hormone replacement therapy (HRT) within the last 3 months;
• patients on other osteoporosis medication within the last 3 months;
• sCTX below lower limit, or above 3 times the upper limit, of normal premenopausal level;
• hypersensitivity to any component of ibandronate;
• contraindication for calcium or vitamin D therapy;
• history of major gastrointestinal upset;
• malignant disease diagnosed within the previous 10 years (except resected basal cell cancer).

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — La Jolla, California, United States
• Study site — Augusta, Georgia, United States
• Study site — Woodbury, Minnesota, United States
• Study site — The Bronx, New York, United States
• Study site — Hopwood, Pennsylvania, United States
• Study site — Madison, Wisconsin, United States
• Study site — Ponce, Puerto Rico
• Study site — San Juan, Puerto Rico
• Study site — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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