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

Status:	Completed
Conditions:	Osteoporosis, Osteoporosis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	65 - Any
Updated:	4/21/2016
Start Date:	February 2006
End Date:	July 2007

A Randomized Double-blind Study to Determine the Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once-monthly Boniva (Ibandronate) Versus Placebo in the Treatment of Post-menopausal Osteoporosis

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 3-12
months, and the target sample size is <100 individuals.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- patients on 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).

We found this trial at

sites

Clinical Trial Facility in Woodbury Minnesota

Woodbury, Minnesota 55125

from

Woodbury, MN