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NCT02635997 Clinical Trial

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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02635997
Other study ID # Catholic University
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date June 2015

Study information
Verified date April 2024
Source Pontifical Catholic University of Argentina
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 425
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• antiresorptive therapy

Locations
Country Name City State
Argentina Catholic University Buenos Aires

Sponsors (1)
Lead Sponsor Collaborator
Pontifical Catholic University of Argentina

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Bone Mineral Density 6 months
Primary Health-Related Quality of Life 6 months
Secondary Adverse Events 6 months
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