Novel Precision Medicine Approach to Treatment of Osteoporosis Based on Bone Turnover

• Status: Recruiting
• Trial end date: 2026-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hartmut Malluche, MD
• Collaborator: National Institute on Aging (NIA)
• Treatments: Alendronate; Teriparatide

Criteria

Inclusion Criteria:

1. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures);

2. Age ≥ 40 years;

3. Females;

4. White race;

5. Normal levels of Vitamin D, and

6. 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:

1. Malignancy within the prior 5 years metastatic to bone or requiring chemotherapy (except non-melanoma skin cancers or cervical carcinoma in situ);

2. Metabolic bone diseases (including osteomalacia, primary hyperparathyroidism and other hypercalcemic disorders, Osteogenesis Imperfecta, Paget's disease, etc.);

3. Endocrinopathy (e.g., current hyperthyroidism, untreated hypothyroidism, Cushing's syndrome;

4. Other medical diseases (e.g., eating disorders, end stage liver, heart or lung disease, intestinal malabsorption, chronic kidney disease stages 2-5D);

5. Any use of antiresorbers (e.g., alendronate, actonel, denosumab) or use within the last two years of anabolic agents (e.g., teriparatide, abaloparatide);

6. Use within the prior year of glucocorticoids, hormone replacement therapy, calcitonin, selective estrogen receptor modulators or phenytoin;

7. Pregnancy, desire to get pregnant, or nursing;

8. Allergy to tetracycline;

9. prior external beam or implant radiation therapy;

10. use of non-aspirin anticoagulants that cannot be safely stopped for the biopsy;

11. prisoners; and

12. radius BMD t-score ≤ -3.5.