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OpenTrials
Completed

NCT Number: NCT02635997

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Catholic University

Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

antiresorptive therapy

Drug

Primary outcomes

  1. Bone Mineral Density

    Time frame: 6 months

  2. Health-Related Quality of Life

    Time frame: 6 months

Secondary outcomes

  1. Adverse Events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Pontifical Catholic University of Argentina

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 21, 2015
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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