Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT00346658
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT00346658
Study Brief:
Protocol Section:
NCT00346658