A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia.

January 25, 2017 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Effect of Oral Monthly Bonviva on in Vivo Bone Micro-architecture Parameters in Post-menopausal Women With Osteopenia

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
      • Paris, France, 75475
      • Saint-priest En Jarez, France, 42277
      • Toulouse, France, 31059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • post-menopausal women, aged 55-75 years;
  • diagnosed osteopenia.

Exclusion Criteria:

  • history of osteoporotic vertebral fracture;
  • contraindication to ibandronate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 2 years
Placebo Comparator: 2
Drug: Placebo
po monthly for 2 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Trabecular BV/TV at distal radius of non-dominant arm
Time Frame: 12 arms
12 arms

Secondary Outcome Measures

Outcome Measure
Time Frame
Trabecular BV/TV at distal radius of non-dominant arm
Time Frame: 6 months and 2 years
6 months and 2 years
Bone density, trabecular BV/TV at distal tibia
Time Frame: 6 months, 1 and 2 years
6 months, 1 and 2 years
Serum CTX
Time Frame: Intervals throughout study
Intervals throughout study
Lumbar hip and wrist BMD
Time Frame: 1 and 2 years
1 and 2 years
AEs and laboratory parameters
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 16, 2007

First Submitted That Met QC Criteria

October 16, 2007

First Posted (Estimate)

October 17, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML19357

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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