Precision Medicine Approach for Osteoporosis - Follow Up Study

Launched by PAUL F NETZEL · Feb 9, 2024

Keywords

ClinConnect Summary

This will be a prospective, longitudinal crossover trial for participants who have completed therapy in the main trial - Novel precision medicine approach to treatment of osteoporosis based on bone turnover. EIRB#70781.

Participants will be informed of the continuation / follow-up study at enrollment into the main trial. Participants will be approached for further participation in the continuation trial near the end of the initial 12 months treatment period. Consent will be obtained at the final visit of the main trial and crossover therapy will be initiated at that time.

Participants in ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosed Osteoporosis by DXA (BMD t-score = -2.5 with or without fragility fractures)
• • 2. Prior enrollment and completion of therapy in the "Novel precision medicine approach to treatment of osteoporosis based on bone turnover" trial.3) Premenopausal, menopausal, and post-menopausal females.
• • 3. 45 years old and older.
• • 4. Normal levels of Vitamin D
• • 5. Absence of all exclusion criteria on clinical workup. Patients diagnosed as osteoporotic due to the presence of
• Exclusion Criteria:
• • 1. Pregnant or trying to become pregnant or are breastfeeding
• • 2. Use of systemic anticoagulation (blood thinner)
• • 3. Planned or anticipated oral surgery within the next 12 months
• • 4. Planning to move out of the area within 18 months of the study
• • 5. Inability to stand or sit upright for at least 30 minutes
• • 6. Chronic alcoholism and/or drug addiction
• • 7. Prior radiation therapy (external beam or implant radiation) involving the skeleton (only if randomized to the bone forming drug (anabolic Forteo®))
• • 8. Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus)
• • 9. Clinical condition that may limit study participation (e.g., heart diseases (unstable angina), lung diseases (severe COPD), other infections)
• • 10. 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)
• • 11. Have other bone diseases that are not linked to age or menopause
• • 12. Have a history of malignancy (cancer), not including non-melanoma skin cancer.
• • 13. Vitamin D (Calcidiol) level below the normal range (below 20ng/mL).