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).