Magnesium Supplementation to Prevent Bone Loss - Full Text View

Sponsor:	University of Tennessee
Collaborator:	National Center for Research Resources (NCRR)
Information provided by:	University of Tennessee
ClinicalTrials.gov Identifier:	NCT00346658

Purpose

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	Intervention	Phase
Osteoporosis	Drug: magnesium	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Magnesium Supplementation to Prevent Bone Loss

Resource links provided by NLM:

MedlinePlus related topics: Calcium Dietary Supplements Osteoporosis

Drug Information available for: Magnesium

U.S. FDA Resources

Further study details as provided by University of Tennessee:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	74
Study Start Date:	July 2002
Estimated Study Completion Date:	September 2006

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.

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00346658

Locations

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)

Investigators

Principal Investigator:

Kathryn M Ryder, MD, MS

University of Tennessee Health Sciences Center

More Information

No publications provided

Study ID Numbers:	RR16047, 5 K23 RR016047
Study First Received:	June 28, 2006
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00346658 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Tennessee:

Osteoporosis
bone density
magnesium
vitamin D

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on November 27, 2009