Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover (NCT05151484) | Clinical Trial Compass
RecruitingPhase 4
Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
United States60 participantsStarted 2022-03-21
Plain-language summary
Osteoporosis affects 24.5% of women over 65 and results in fracture-related hospital admissions exceeding those of heart attacks, strokes and breast cancer combined. Current treatment options do not account for differences between age-related and estrogen deficiency related osteoporosis, because of the need for bone biopsies for determination. This study will establish a paradigm-shifting individualized treatment protocol for age-related osteoporosis and a non-invasive method for its determination, thereby reducing the major health problems and enormous burden on society and the elderly related to this disease.
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures)
✓. Treatment naive with respect to with anabolic or antiresorptive bone drugs.
✓. Premenopausal, menopausal, and post-menopausal females.
✓. 45 years old and older.
✓. Presence or absence of diabetes
✓. Normal levels of Vitamin D
Exclusion criteria
✕. Pregnant or trying to become pregnant or are breastfeeding.
✕. Participation in a study of an investigational drug during the past 30 days.
✕. Treatment with anabolic or antiresorptive bone drugs.
✕. Use of systemic anticoagulation (blood thinner)
✕. Planned or anticipated oral surgery within the next 12 months.
What they're measuring
1
Mineral Bone Density of the lumbar spine
Timeframe: 1 Year
2
Measure of serum osteocalcin levels to predict bone turnover