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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00545207

Recruitment Status : Completed

First Posted : October 17, 2007

Last Update Posted : January 26, 2017

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

Tracking Information

First Submitted Date ^ICMJE

October 16, 2007

First Posted Date ^ICMJE

October 17, 2007

Last Update Posted Date

January 26, 2017

Study Start Date ^ICMJE

Not Provided

Actual Primary Completion Date

September 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Trabecular BV/TV at distal radius of non-dominant arm at 1 year.

Change History

Complete list of historical versions of study NCT00545207 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Efficacy: Trabecular BV/TV at distal radius of non-dominant arm at 6 months and 2 years; bone density, trabecular BV/TV at distal tibia at 6 months, 1 and 2 years; serum CTX; lumbar, hip and wrist BMD at 1 and 2 years. Safety: AEs and laboratory tests.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Post-Menopausal Osteopenia

Intervention ^ICMJE

Drug: ibandronate [Bonviva/Boniva]
150mg po monthly for 2 years
Drug: Placebo
po monthly for 2 years

Study Arms

Experimental: 1
Intervention: Drug: ibandronate [Bonviva/Boniva]
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

150

Original Enrollment ^ICMJE

Not Provided

Actual Study Completion Date

September 2010

Actual Primary Completion Date

September 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

history of osteoporotic vertebral fracture;
contraindication to ibandronate.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

55 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00545207

Other Study ID Numbers ^ICMJE

ML19357

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

PRS Account

Hoffmann-La Roche

Verification Date

January 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top