drugset / Trial / NCT00303485

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

NCT00303485

Phase 4 Completed 67 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-02
Primary completion
2007-06
Completion
2007-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 150 mg Oral
Background Calcium carbonate Other / unclassified 500 mg
Background Vitamin D Other / unclassified 200 iu