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Magnesium Supplementation to Prevent Bone Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00346658
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : December 15, 2008
National Center for Research Resources (NCRR)
Information provided by:
University of Tennessee

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: magnesium Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Magnesium Supplementation to Prevent Bone Loss
Study Start Date : July 2002
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Magnesium

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00346658

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United States, Tennessee
University of Tennessee Health Sciences Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
National Center for Research Resources (NCRR)
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Principal Investigator: Kathryn M Ryder, MD, MS University of Tennessee Health Sciences Center
Layout table for additonal information Identifier: NCT00346658    
Other Study ID Numbers: RR16047
5K23RR016047 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2006    Key Record Dates
Last Update Posted: December 15, 2008
Last Verified: December 2008
Keywords provided by University of Tennessee:
bone density
vitamin D
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases