Magnesium Supplementation to Prevent Bone Loss

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00346658
First received: June 28, 2006
Last updated: December 12, 2008
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: magnesium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Magnesium Supplementation to Prevent Bone Loss

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Biomarkers bone turnover (P1NP and CTX)
  • Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)

Secondary Outcome Measures:
  • Change in BMD at the spine, femoral neck and total hip by DXA
  • Change in RBC magnesium

Estimated Enrollment: 74
Study Start Date: July 2002
Estimated Study Completion Date: September 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346658

Locations
United States, Tennessee
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Kathryn M Ryder, MD, MS University of Tennessee Health Sciences Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346658     History of Changes
Other Study ID Numbers: RR16047, 5 K23 RR016047
Study First Received: June 28, 2006
Last Updated: December 12, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Osteoporosis
bone density
magnesium
vitamin D

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 26, 2014