Precision Medicine Approach for Osteoporosis - Follow Up Study

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 Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months. Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continued on Alendronate for 12 months.

• Alendronate (Drug), also known as Grp 1: Participants in Group 1 low turnover, who have received Teriparatide in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Alendronate for 12 months.
• Teriparatide (Drug), also known as Grp 2: Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant did not respond well to therapy; will be assigned to Teriparatide for 12 months.
• Alendronate (Drug), also known as Grp 2c: Participants in Group 2 low turnover who received Alendronate in the main trial and if it is determined that the participant responded to therapy; will be continue on Alendronate for 12 months.

Primary outcomes

• Percent change in bone loss [12 months]: The primary endpoint for the follow up study will be bone loss as determined by the percent change in DXA absolute values of the lumbar spine, femoral neck, total hip and radius measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.

Secondary outcomes

• Percent change in Bone Mass Density at the hip [12 months]: Secondary endpoints will be percent change in BMD at the hip measured at baseline, at the end of the one-year trial; and at end of the one year follow up study. DXA is chosen because of its wide availability, low radioactivity exposure, and clinical use.

Other outcomes

• Trabecular bone score (TBS) [12 months]: A measure of trabecular texture derived from lumbar spine DXA images measure of trabecular texture derived from lumbar spine DXA images which predicts fracture independently of BMD. TBS is calculated as the slope of the log-log transform of the 2D variogram, where the slope characterizes the rate of gray-level amplitude variations. A steep variogram slope with a high TBS value is associated with better bone structure, whereas low TBS values indicate worse bone structure.

Sex: Female, ages: 45 Years to any

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).

• Paul Netzel, DNP, Principal investigator, University of Kentucky