Antiresorptive Effects of a 6-m Treatment Course With Ibandronate Plus Supplementation of Vitamine D and Calcium in Central America

NCT ID: NCT02635997

Last Updated: 2024-04-08

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

425 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-06-30

Brief Summary

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Ibandronate is a third-generation biphosphonate with recognized antiresorptive efficacy by several international, randomized, double-blind, controlled trials. These studies have not included patients from central america, to the best of our knowledge. Therefore, this open-label, uncontrolled study, was set out to assess the clinical effects of a 6-m treatment course with Ibandronate plus vitamine D and Calcium on bone mineral density and health-related quality of life.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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patients on antiresorptive therapy

Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day

antiresorptive therapy

Intervention Type DRUG

Interventions

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antiresorptive therapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with a diagnosis of osteoporosis of at-Risk
* Have a medical indication to receive Ibandronate+Vitamine D+Calcium

Exclusion Criteria

* Osteoporosis due to secondary causes
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pontifical Catholic University of Argentina

OTHER

Sponsor Role lead

Responsible Party

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Santiago Perez Lloret

Associate Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University

Buenos Aires, , Argentina

Site Status

Countries

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Argentina

Other Identifiers

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Catholic University

Identifier Type: -

Identifier Source: org_study_id

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