A Randomized Double-Blinded Superiority Trial to Compare the Efficacy of Vitamin D3 and Calcium versus placebo in Prevention of Hip Fractures in Elderly Women

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Lorenzo Fagotti
Marcos Balbino
Thaís Bispo Gonzalez Truffa
Carolina Susanna
Javier Calvo-Marin
Juan Carlos M Fuentes B
Jose María Carrasco Rueda
Luiz Guilherme Villares da Costa

Abstract

Background and Aim: The role of vitamin D plus calcium to protect against hip fracture in postmenopausal women remains controversial. Two major studies on this subject presented diverse outcomes; they implemented different doses of Vitamin D and Calcium, and they studied different populations. One study found evidence that Calcium plus Vitamin D do protect against fractures; the second study failed to demonstrate such protection. The aim of the present study is to test the hypothesis that a higher dose of vitamin D plus calcium is effective in reducing hip fractures in non-osteoporotic elderly women when compared to placebo.
Methods: This will be a randomized, double-blinded superiority, multicenter trial involving three centers in São Paulo, Lima and Mexico City. After a three-month run-in period, 7176 participants will receive Calcium + Vitamin D or Placebo. The primary outcome is the occurrence of hip fractures assessed by the pelvic radiographic image; secondary outcomes include other fractures, the variation of Bone Mass Density, and the adverse effects rate.
Conclusion: There is an increase in morbidity, mortality, and costs resulting from hip fractures since it is an important risk fact following accidents. A possible lack of benefit inside the active group drives more attention to an eventual over-prescription of those substances. Therefore, further studies including a phase II trial with different exclusion criteria could be desirable to confirm these findings and help to reduce the incidence of hip fractures..
Key-Words: Hip Fractures, Bone Loss, Postmenopausal, Vitamin D Deficiency, Bone Density, Calcium, Dietary, Osteopenia, Postmenopausal Osteoporosis, Design, Research Protocol, Clinical Research.

Article Details

How to Cite
Fagotti, L., Balbino, M., Bispo Gonzalez Truffa, T., Susanna, C., Calvo-Marin, J., M Fuentes B, J. C., Carrasco Rueda, J. M., & Villares da Costa, L. G. (2016). A Randomized Double-Blinded Superiority Trial to Compare the Efficacy of Vitamin D3 and Calcium versus placebo in Prevention of Hip Fractures in Elderly Women. Principles and Practice of Clinical Research, 2(1). Retrieved from https://journal.ppcr.org/index.php/ppcrjournal/article/view/27
Section
Study Design

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