Postmenopausal Osteoporosis Clinical Trial
Official title:
A 12-week, Open-label Study to Evaluate the Effect of MBP-80 (200g of Yogurt With Fortified Calcium Content and MBP 80 mg) on Bone Remodelling as Assessed by Bone Turnover Markers in Early Postmenopausal Women
This study will determine if daily oral intake of 200g of a marketed yogurt with fortified calcium content and a milk basic protein (MBP)80 mg benefits on bone cells activity in postmenopausal women. The efficacy of the product is measured by examining the variation of biochemical markers of bone turnover. MBP 80 is a particular protein contained in milk; it has been added to the yogurt provided for this study. The effects of MBP 80 on the quality of bone tissue have not yet been proven.
The morbidity and mortality associated with osteoporotic related fractures is devastating in
terms of disability to an individual and cost to the global economy. As the world's
population ages, this will present a major public health issue since a larger proportion of
women remain undiagnosed and untreated even with the availability of therapies and calcium
and vitamin D supplements. Consequently, it remains important to evaluate dairy products
(milk, cheese, and yogurt) that can be safely provided as a supplement for bone health in
addition to the current pharmacological treatments.
The rationale of this study is to assess the beneficial effect of a daily dietary supplement
of MBP 80 mg in a yogurt matrix with fortified calcium content on bone remodelling in
healthy early postmenopausal women with neither osteoporosis nor estrogens/progestin
therapy.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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