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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01900860
Eligibility Criteria:
Inclusion Criteria:
* Healthy women and men between 55 and 70 years of age; women will be at least 5 years post-menopause. Presence of a chronic illness does not exclude participation if the condition is stable and managed by a physician.
* Baseline lumbar spine and total hip bone mineral density (BMD) T-score above 2.5 as assessed using dual x-ray absorptiometry (DXA).
Exclusion Criteria:
* A serum 25-\[OH\] vitamin D (25OHD) of \<30 nmol/L (\<12 ng/mL) or \>125 nmol/L (50 ng/mL).
* Hypercalcemia (serum calcium \>2.55 mmol/L), hypocalcemia (serum calcium \<2.10 mmol/L) or eGFR \<30 mL/min.
* Surgical cure of Primary Hyperparathyroidism within the last year.
* Active kidney stone disease (recurrent stones, recent kidney stone \[within last 2 years\])
* Known hypersensitivity or allergy to Vitamin D
* Serum creatinine, AST, ALT, PTH, calcium, or alkaline phosphatase greater than 1.5 times the upper limit of normal at the screening visit
* BMD exclusions:
1. High 10-year risk for osteoporotic fracture, as defined by the Canadian Association of Radiologists/Osteoporosis Canada calculator, or the World Health Organization's FRAX calculator.
2. DXA T-score below or equal to -2.5 SD.
* Have taken bone active osteoporosis prescription drugs in the past 2 years (bisphosphonates) or 1 year (other osteoporosis prescription therapies).
* Any medical condition that would prevent participation in a clinical trial for a full three years.
* Medications such as prednisone \>2.5 mg daily (or equivalent); other bone active medications such as tamoxifen or aromatase inhibitors for breast cancer, or androgen deprivation therapy of prostate cancer.
* Disorders known to affect vitamin D metabolism such as sarcoidosis or renal failure or malabsorption disorders (e.g. pancreatic insufficiency or celiac disease).
* Regular (monthly or more frequent) use of tanning salons.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT01900860
Study Brief:
Protocol Section:
NCT01900860