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Magnesium Supplementation to Prevent Bone Loss

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
magnesium
Sponsored by
University of Tennessee
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring Osteoporosis, bone density, magnesium, vitamin D

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University of Tennessee Health Sciences Center

Outcomes

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

Full Information

First Posted
June 28, 2006
Last Updated
December 12, 2008
Sponsor
University of Tennessee
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00346658
Brief Title
Magnesium Supplementation to Prevent Bone Loss
Official Title
Magnesium Supplementation to Prevent Bone Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Tennessee
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, bone density, magnesium, vitamin D

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
74 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
magnesium
Primary Outcome Measure Information:
Title
Biomarkers bone turnover (P1NP and CTX)
Title
Calcium regulating hormones (PTH and 1,25 dihydroxyvitamin D)
Secondary Outcome Measure Information:
Title
Change in BMD at the spine, femoral neck and total hip by DXA
Title
Change in RBC magnesium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn M Ryder, MD, MS
Organizational Affiliation
University of Tennessee Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Sciences Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

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