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RECRUITING

NCT05151484

PHASE4

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

Sponsor: Madhumathi Rao

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-03-21

Completion Date

2026-08-31

Last Updated

2025-04-24

Healthy Volunteers

Conditions

Age-Related Osteoporosis

Interventions

DRUG

Teriparatide

Participants will receive 20 μg teriparatide per day via subcutaneous injections. Participants, and if needed a caregiver, will be trained in the subcutaneous administration of teriparatide according to the manufacturer's guidelines. The investigators will measure serum calcium, BSAP and TRAP-5b levels via blood draws at quarterly monitoring visits. If BSAP or TRAP-5b do not increase compared to baseline or decrease after any quarter, participants will be contacted and correct administration will be reviewed. Serum calcium is measured for safety to avoid hypo- and hypercalcemia. Participants will also be given a daily dose of Vitamin D of 800 IUs to prevent development of Vitamin D deficiency.

DRUG

Alendronate

Participants will receive 70 mg alendronate p.o. once per week. Participants will be carefully instructed to follow the manufacturer's recommendations for administration. Compliance will be assessed by measurement of the bone turnover markers BSAP and TRAP-5b from blood drawn at quarterly monitoring visits. These markers have been shown to be useful for assessment of turnover changes with treatment. If these markers do not decrease compared to baseline or rise after any quarter, participants will be contacted and correct administration will be reviewed. Participants will also be given a daily dose of Vitamin D of 800 IUs to prevent development of Vitamin D deficiency.

Inclusion Criteria: 1. Diagnosed Osteoporosis by DXA (BMD t-score ≤ -2.5 with or without fragility fractures) 2. Treatment naive with respect to with anabolic or antiresorptive bone drugs. 3. Premenopausal, menopausal, and post-menopausal females. 4. 45 years old and older. 5. Presence or absence of diabetes 6. Normal levels of Vitamin D 7. 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. Pregnant or trying to become pregnant or are breastfeeding. 2. Participation in a study of an investigational drug during the past 30 days. 3. Treatment with anabolic or antiresorptive bone drugs. 4. Use of systemic anticoagulation (blood thinner) 5. Planned or anticipated oral surgery within the next 12 months. 6. Allergy to the antibiotics demeclocycline or tetracycline. 7. Planning to move out of the area within 18 months of the study. 8. Inability to stand or sit upright for at least 30 minutes. 9. Chronic alcoholism and/or drug addiction. 10. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®)). 11. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 Diabetes Mellitus). 12. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections). 13. Abnormalities of the esophagus (tube connecting the mouth to the stomach) which delay esophageal emptying such as stricture (narrowing) or achalasia (a condition that prevents normal swallowing). 14. Have other bone diseases that are not linked to age or menopause. 15. Have a history of malignancy (cancer), not including non-melanoma skin cancer. 16. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL). 17. AFTER RANDOMIZATION: If randomized to Group 1 Teriparatide and radius BMD t-score is less than -3.5 and does not sign consent to continue in the study.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States