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Magnesium Supplementation to Prevent Bone Loss
This study has been completed.
Study NCT00346658   Information provided by University of Tennessee
First Received: June 28, 2006   Last Updated: December 12, 2008   History of Changes

June 28, 2006
December 12, 2008
July 2002
 
  • Biomarkers bone turnover (P1NP and CTX)
  • Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)
Same as current
Complete list of historical versions of study NCT00346658 on ClinicalTrials.gov Archive Site
  • Change in BMD at the spine, femoral neck and total hip by DXA
  • Change in RBC magnesium
Same as current
 
Magnesium Supplementation to Prevent Bone Loss
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.

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.

Phase I
Interventional
Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Osteoporosis
Drug: magnesium
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
74
September 2006
 

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
Both
55 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00346658
 
RR16047, 5 K23 RR016047
University of Tennessee
National Center for Research Resources (NCRR)
Principal Investigator: Kathryn M Ryder, MD, MS University of Tennessee Health Sciences Center
University of Tennessee
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP