New treatment approach for age-related osteoporosis

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

This study is testing a new personalized treatment for osteoporosis in older adults to see if using specific medications can help strengthen their bones and prevent fractures.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT05151484 on ClinicalTrials.gov

What this trial studies

This study aims to develop a personalized treatment protocol for age-related osteoporosis by distinguishing it from estrogen deficiency-related osteoporosis. It will utilize a non-invasive method to assess bone turnover, allowing for tailored therapies that address the unique needs of older patients. The intervention involves administering Teriparatide and Alendronate to treatment-naive individuals diagnosed with osteoporosis. By focusing on low bone turnover, the study seeks to improve treatment outcomes and reduce the burden of osteoporotic fractures in the elderly.

Who should consider this trial

Good fit: Ideal candidates include women aged 45 and older diagnosed with osteoporosis who have not previously received anabolic or antiresorptive treatments.

Not a fit: Patients with osteoporosis due to fragility fractures without osteoporotic t-scores will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment efficacy for patients with age-related osteoporosis, reducing fracture risk and associated healthcare costs.

How similar studies have performed: While there have been studies addressing osteoporosis, this precision medicine approach focusing specifically on age-related osteoporosis is relatively novel.

Eligibility criteria

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.

Where this trial is running

Lexington, Kentucky

• University of Kentucky — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Madhumathi Rao, MD — University of Kentucky
• Study coordinator: Madhumathi Rao, MD

Conditions Age-Related Osteoporosis