Magnesium Supplementation to Prevent Bone Loss
2 other identifiers
interventional
74
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2002
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
June 28, 2006
CompletedFirst Posted
Study publicly available on registry
June 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedDecember 15, 2008
December 1, 2008
June 28, 2006
December 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biomarkers bone turnover (P1NP and CTX)
Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)
Secondary Outcomes (2)
Change in BMD at the spine, femoral neck and total hip by DXA
Change in RBC magnesium
Interventions
Eligibility Criteria
You may qualify if:
- Healthy ambulatory men and women between the ages of 55-75 years
- Women at least 5 years after menopause
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee Health Sciences Center
Memphis, Tennessee, 38163, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn M Ryder, MD, MS
University of Tennessee Health Sciences Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 28, 2006
First Posted
June 30, 2006
Study Start
July 1, 2002
Study Completion
September 1, 2006
Last Updated
December 15, 2008
Record last verified: 2008-12