Magnesium Supplementation to Prevent Bone Loss

December 12, 2008 updated by: University of Tennessee
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

74

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Biomarkers bone turnover (P1NP and CTX)
Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)

Secondary Outcome Measures

Outcome Measure
Change in BMD at the spine, femoral neck and total hip by DXA
Change in RBC magnesium

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Kathryn M Ryder, MD, MS, University of Tennessee Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

September 1, 2006

Study Registration Dates

First Submitted

June 28, 2006

First Submitted That Met QC Criteria

June 28, 2006

First Posted (ESTIMATE)

June 30, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 15, 2008

Last Update Submitted That Met QC Criteria

December 12, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RR16047
  • 5K23RR016047 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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