CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 67 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
ibandronate [Bonviva/Boniva] 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00303485
NCT00303485Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Study to Determine Time to Onset of Suppression of the Bone Resorption Marker sCTX With Once Monthly Ibandronate in the Treatment of Postmenopausal Osteoporosis

Hoffmann-La Roche·interventional·Posted Mar 17, 2006·Updated May 2, 2016

In Brief

A Phase 4 clinical trial evaluating Placebo, Vitamin D and calcium supplementation, and 1 other intervention for Post Menopausal Osteoporosis. Completed, enrolled 67 participants across 10 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Menopausal Osteoporosis
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2006
Enrollment StartFeb 1, 2006
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 20.3 years ago

Interventions

Placebodrug

po monthly for 6 months

Vitamin D and calcium supplementationdrug

As prescribed

ibandronate [Bonviva/Boniva]drug

150mg po monthly for 6 months