Magnesium Supplementation to Prevent Bone Loss

Osteoporosis Clinical Trial

Official title:

Magnesium Supplementation to Prevent Bone Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346658
• Other study ID #: RR16047
• Secondary ID: 5K23RR016047
• Status: Completed
• Phase: Phase 1
• First received: June 28, 2006
• Last updated: December 12, 2008
• Start date: July 2002
• Est. completion date: September 2006

Study information

• Verified date: December 2008
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Extreme magnesium deficiency is known to have an impact on the synthesis, secretion and/or action of calcium regulating hormones. Many older adults are at risk for less severe magnesium deficiency, since the majority of adults receive less than the Recommended Daily Allowance of magnesium. We hypothesize that magnesium supplementation will have a beneficial effect on calcium regulating hormones and markers of bone turnover.

Description:

This is a 12 month randomized, double-blind, placebo-controlled study of magnesium supplementation. Our hypothesis was that magnesium supplementation would decrease bone turnover markers and alter calcium-regulating hormones: parathyroid hormone and 1, 25 dihydroxyvitamin D.

Male and female adults over 55 without with a T-score at the hip above -2 are randomized to magnesium 250 mg BID or identical placebo BID. At baseline, all participants had a bone mineral density (BMD) by DXA scan at the hip and spine, blood biomarkers of bone resorption and formation, and calcium regulating hormones. Participants were followed for 12 months, with repeat measurement of calcium regulating hormones and bone turnover markers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Healthy ambulatory men and women between the ages of 55-75 years

2. Women at least 5 years after menopause

Exclusion Criteria:

1. Inability to give informed consent in accordance with institutional guidelines

2. Creatinine greater than or equal to 2 mg/dl, since magnesium is excreted by the kidneys

3. Diarrhea or loose frequent stools (> 2 a day) at least 3 days/ week in last 3 months

4. Use within 12 months of estrogen, bisphosphonates, calcitonin, or raloxifene

5. Current use of loop diuretics

6. Use within 12 months of corticosteroids

7. History of hyperparathyroidism, hyperthyroidism, or osteomalacia within past 12 month

8. Vitamin D deficient as measured by 25-hydroxyvitamin D outside of the normal range

9. Magnesium supplementation of greater than 250 mg/day

10. Calcium supplementation of greater than 1500 mg/day

11. Conditions which, in the opinion of the investigator, would interfere with the evaluation of BMD at the spine including severe scoliosis, osteophytosis and lumbar fusion

12. Bilateral hip replacement

13. BMD at the lumbar spine L2-L4 of less than 0.859g/cm2 for women or 0.895 g/cm2 in men; or total hip less than 0.698 g/cm2 for women or 0.731 g/cm2 for men; or femoral neck less than 0.627 g/cm2 for women or 0.658 g/cm2 for men This represents a T-score of less than -2 at each site

14. High serum calcium on screening blood test

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• magnesium

Locations

Country	Name	City	State
United States	University of Tennessee Health Sciences Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Tennessee	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers bone turnover (P1NP and CTX)
Primary	Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)
Secondary	Change in BMD at the spine, femoral neck and total hip by DXA
Secondary	Change in RBC magnesium