A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

NCT ID: NCT00081653

Last Updated: 2017-07-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

719 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2008-05-31

Brief Summary

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This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed Description

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Conditions

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Post-Menopausal Osteoporosis

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 3 years

2

Group Type ACTIVE_COMPARATOR

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

100mg po monthly for 3 years

Interventions

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ibandronate [Bonviva/Boniva]

150mg po monthly for 3 years

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

100mg po monthly for 3 years

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* successful completion of Bonviva study BM16549, with at least 75% compliance;
* ambulatory.

Exclusion Criteria

* malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
* breast cancer diagnosed within the previous 22 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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Loma Linda, California, United States

Site Status

Lakewood, Colorado, United States

Site Status

Omaha, Nebraska, United States

Site Status

Livingston, New Jersey, United States

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Portland, Oregon, United States

Site Status

Liège, , Belgium

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Merksem, , Belgium

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São Paulo, , Brazil

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Pilsen, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Ballerup Municipality, , Denmark

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Vejle, , Denmark

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Lyon, , France

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Berlin, , Germany

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Hanover, , Germany

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Balatonfüred, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Kiskunhalas, , Hungary

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Zalaegerszeg, , Hungary

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Siena, , Italy

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León, , Mexico

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Obregón, , Mexico

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Haugesund, , Norway

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Stavanger, , Norway

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Krakow, , Poland

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Warsaw, , Poland

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Barcelona, , Spain

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Madrid, , Spain

Site Status

Southampton, , United Kingdom

Site Status

Countries

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United States Belgium Brazil Czechia Denmark France Germany Hungary Italy Mexico Norway Poland Spain United Kingdom

Other Identifiers

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MA17903

Identifier Type: -

Identifier Source: org_study_id

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