Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover
Age-Related Osteoporosis
About this trial
This is an interventional treatment trial for Age-Related Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures);
- Age ≥ 40 years;
- Females;
- White race;
- Normal levels of Vitamin D, and
- Absence of all exclusion criteria on clinical workup.
Patients diagnosed as osteoporotic due to the presence of fragility fractures, but without osteoporotic t-scores, will not be included because they would require fractures as a study endpoint which would entail a multi-center approach. Moreover, abnormal bone quality has been shown to be present in these patients, which requires bone histology for assessment.
Exclusion Criteria:
- Malignancy within the prior 5 years metastatic to bone or requiring chemotherapy (except non-melanoma skin cancers or cervical carcinoma in situ);
- Metabolic bone diseases (including osteomalacia, primary hyperparathyroidism and other hypercalcemic disorders, Osteogenesis Imperfecta, Paget's disease, etc.);
- Endocrinopathy (e.g., current hyperthyroidism, untreated hypothyroidism, Cushing's syndrome;
- Other medical diseases (e.g., eating disorders, end stage liver, heart or lung disease, intestinal malabsorption, chronic kidney disease stages 2-5D);
- Any use of antiresorbers (e.g., alendronate, actonel, denosumab) or use within the last two years of anabolic agents (e.g., teriparatide, abaloparatide);
- Use within the prior year of glucocorticoids, hormone replacement therapy, calcitonin, selective estrogen receptor modulators or phenytoin;
- Pregnancy, desire to get pregnant, or nursing;
- Allergy to tetracycline;
- prior external beam or implant radiation therapy;
- use of non-aspirin anticoagulants that cannot be safely stopped for the biopsy;
- prisoners; and
- radius BMD t-score ≤ -3.5.
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Group 1 Low Turnover
Group 2 Low Turnover
Group 3 Normal-High Turnover
Teriparatide (anabolic) For 1 Year
Standard of Care - Control: Treated with Alendronate (antiresorber) For 1 Year
Standard of Care Treatment with Alendronate (antiresorber) For 1 Year