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A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis

NCT ID: NCT01128257

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

COMPLETED

Total Enrollment

6054 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-12-31

Brief Summary

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This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \[Bonviva/Boniva\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.

Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

ibandronate [Bonviva/Boniva]

Intervention Type DRUG

As prescribed by physician

2

alendronate

Intervention Type DRUG

As prescribed by physician

Interventions

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alendronate

As prescribed by physician

Intervention Type DRUG

ibandronate [Bonviva/Boniva]

As prescribed by physician

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 55 years of age
* Postmenopausal osteoporosis
* Patients who are in the opinion of the physician eligible to participate in this study

Exclusion Criteria

* N/A
Minimum Eligible Age

55 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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Marburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML22927

Identifier Type: -

Identifier Source: org_study_id