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BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

NCT ID: NCT00545779

Last Updated: 2016-10-28

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

PHASE3

Total Enrollment

677 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-10-31

Brief Summary

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This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. 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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Ibandronate

Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

150 mg orally once monthly for 6 months

Interventions

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Ibandronate

150 mg orally once monthly for 6 months

Intervention Type DRUG

Other Intervention Names

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[Bonviva/Boniva]

Eligibility Criteria

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Inclusion Criteria

* post-menopausal women;
* \>=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

Exclusion Criteria

* inability to stand or sit in an upright position for at least 60 minutes;
* hypersensitivity to bisphosphonates;
* treatment with other drugs affecting bone metabolism;
* abnormalities of the oesophagus, which delay oesophageal emptying.
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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Tirana, , Albania

Site Status

Banja Luka, , Bosnia and Herzegovina

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Sarajevo, , Bosnia and Herzegovina

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Sarajevo, , Bosnia and Herzegovina

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Tuzla, , Bosnia and Herzegovina

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Rijeka, , Croatia

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Slavonski Brod, , Croatia

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Split, , Croatia

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Zagreb, , Croatia

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Skopje, , North Macedonia

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Belgrade, , Serbia

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Niška Banja, , Serbia

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Novi Sad, , Serbia

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Adana, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Antalya, , Turkey (Türkiye)

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Aydin, , Turkey (Türkiye)

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Bursa, , Turkey (Türkiye)

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Denizli, , Turkey (Türkiye)

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Erzurum, , Turkey (Türkiye)

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Gaziantep, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kayseri, , Turkey (Türkiye)

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Konya, , Turkey (Türkiye)

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Manisa, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Trabzon, , Turkey (Türkiye)

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Countries

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Serbia and Montenegro Albania Bosnia and Herzegovina Croatia North Macedonia Serbia Turkey (Türkiye)

Other Identifiers

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ML20430

Identifier Type: -

Identifier Source: org_study_id