Magnesium Supplementation to Prevent Bone Loss

University of Tennessee

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: magnesium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00346658

5K23RR016047 (U.S. NIH Grant/Contract)

RR16047

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

55 to 75 years old

Volunteers

Accepts Healthy Volunteers

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