NCT00303485

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Placebo	po monthly for 6 months
DRUG	Vitamin D and calcium supplementation	As prescribed
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 6 months

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2006-03-17
• Last updated: 2016-05-02
• Results posted: 2016-05-02

Locations

10 sites across 2 countries: United States, Puerto Rico