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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-12-31

Brief Summary

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This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

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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 1 year

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

po monthly for 1 year

Interventions

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Placebo

po monthly for 1 year

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

150mg po monthly for 1 year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women 45-60 years of age;
* post-menopausal;
* ambulatory.

Exclusion Criteria

* vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
* low-trauma osteoporotic fracture in any other bone;
* breast cancer diagnosed within last 20 years;
* other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
* treatment with any bisphosphonate within last 2 years;
* treatment with other drugs affecting bone metabolism within last 6 months.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No