Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteopenia
- Sponsor
- Integrative Health Technologies, Inc.
- Enrollment
- 354
- Locations
- 1
- Primary Endpoint
- Changes in Bone Mineral Density (BMD)
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.
Detailed Description
The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that: 1. improve nutrition, 2. increase health literacy and, 3. increase physical activity. The purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (BMD)in two study groups. Both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin D3, vitamin K and magnesium.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.
Exclusion Criteria
- •Younger the 18 years of age, and
- •Recommendations not to participate from their physicians.
Outcomes
Primary Outcomes
Changes in Bone Mineral Density (BMD)
Time Frame: baseline and 6 months
Measurements of bone mineral density were conducted at baseline and 6 months from baseline in two different study groups following the same bone-health behavior modification plan, but with different versions of a bone-health calcium supplement.
Secondary Outcomes
- A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups(six months)