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

April 4, 2024 updated by: Santiago Perez Lloret, Pontifical Catholic University of Argentina
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

425

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Catholic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women with a diagnosis of osteoporosis o with a high risk of developing it in the near future.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients on antiresorptive therapy
Ibandronate 150 mg per month + Vitamine D 400-800 IU and Calcium 500-1000 mg per day
Drug: antiresorptive therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bone Mineral Density
Time Frame: 6 months
6 months
Health-Related Quality of Life
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontifical Catholic University of Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 13, 2015

First Submitted That Met QC Criteria

December 16, 2015

First Posted (Estimated)

December 21, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Catholic University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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