MedTrace Logo

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

NCT00303485 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2016-05-02

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00303485 on ClinicalTrials.gov