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A Study of Quarterly Intravenous Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

NCT ID: NCT00493532

Last Updated: 2016-11-02

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

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2007-06-30

Study Completion Date

2010-12-31

Brief Summary

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This single arm study will assess the efficacy and safety of quarterly intravenous Bonviva in women with post-menopausal osteoporosis. All patients will receive Bonviva 3mg i.v. every 3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.

Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Interventions

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ibandronate [Bonviva/Boniva]

3mg iv every 3 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* post-menopausal women with osteoporosis;
* \<=80 years of age;
* naive to oral bisphosphonates, or have discontinued daily and/or weekly bisphosphonate treatment for \>1 year.

Exclusion Criteria

* metabolic bone disease other than post-menopausal osteoporosis;
* treatment with other drugs affecting bone metabolism within last 6 months;
* previous or current malignant disease (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer).
Maximum Eligible Age

80 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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Chai Yi, , Taiwan

Site Status

Changhua, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML20882

Identifier Type: -

Identifier Source: org_study_id