NCT01501344

Open-label Study to Evaluate the Effect of MBP-80 on Bone Remodelling

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Groupe De Recherche En Rhumatologie Et Maladies Osseuses Inc. · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	200 g yogurt with fortified calcium content and MBP 80 mg	Intake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks.

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-12-29
• Last updated: 2012-01-09

Locations

1 site across 1 country: Canada