Overview

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

Status:
Completed
Trial end date:
2007-06-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Calcium
Calcium, Dietary
Diphosphonates
Ergocalciferols
Ibandronic Acid
Vitamin D
Vitamins
Criteria
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 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).