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

NCT ID: NCT00545090

Last Updated: 2016-11-10

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

PHASE4

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-06-30

Brief Summary

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This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, 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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

150mg po monthly for 6 months

Interventions

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ibandronate [Bonviva/Boniva]

150mg po monthly for 6 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients responding to oral monthly Bonviva during the BonAdAsia study;
* willing to continue Bonviva treatment for a further 6 months.

Exclusion Criteria

* none specified.
Maximum Eligible Age

85 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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Hong Kong, , Hong Kong

Site Status

Jakarta, , Indonesia

Site Status

Makassar, , Indonesia

Site Status

Surabaya, , Indonesia

Site Status

Manila, , Philippines

Site Status

Quezon City, , Philippines

Site Status

Changhua, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Tainan City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taoyuan District, , Taiwan

Site Status

Bangkok, , Thailand

Site Status

Bangkok, , Thailand

Site Status

Chiang Mai, , Thailand

Site Status

Khon Kaen, , Thailand

Site Status

Countries

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China Hong Kong Indonesia Philippines Taiwan Thailand

Other Identifiers

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ML19937

Identifier Type: -

Identifier Source: org_study_id