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OpenTrials
Completed

NCT Number: NCT00346658

Magnesium Supplementation to Prevent Bone Loss

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.

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Key information

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Tennessee Health Sciences Center

Memphis, Tennessee, 38163, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy ambulatory men and women between the ages of 55-75 years
  • Women at least 5 years after menopause

Exclusion criteria

  • Inability to give informed consent in accordance with institutional guidelines
  • Creatinine greater than or equal to 2 mg/dl, since magnesium is excreted by the kidneys
  • Diarrhea or loose frequent stools (> 2 a day) at least 3 days/ week in last 3 months
  • Use within 12 months of estrogen, bisphosphonates, calcitonin, or raloxifene
  • Current use of loop diuretics
  • Use within 12 months of corticosteroids
  • History of hyperparathyroidism, hyperthyroidism, or osteomalacia within past 12 month
  • Vitamin D deficient as measured by 25-hydroxyvitamin D outside of the normal range
  • Magnesium supplementation of greater than 250 mg/day
  • Calcium supplementation of greater than 1500 mg/day
  • 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
  • Bilateral hip replacement
  • 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
  • High serum calcium on screening blood test

Treatment and study plan

Magnesium

Drug

Primary outcomes

  1. Biomarkers bone turnover (P1NP and CTX)

  2. Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)

Secondary outcomes

  1. Change in BMD at the spine, femoral neck and total hip by DXA

  2. Change in RBC magnesium

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2002
Study completion
2006
First posted
Jun 30, 2006
Registry last updated
Dec 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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