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

NCT ID: NCT00545207

Last Updated: 2017-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Post-Menopausal Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

150mg po monthly for 2 years

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po monthly for 2 years

Interventions

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ibandronate [Bonviva/Boniva]

150mg po monthly for 2 years

Intervention Type DRUG

Placebo

po monthly for 2 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* history of osteoporotic vertebral fracture;
* contraindication to ibandronate.
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Lyon, , France

Site Status

Paris, , France

Site Status

Saint-Priest-en-Jarez, , France

Site Status

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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ML19357

Identifier Type: -

Identifier Source: org_study_id

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