Anabolic Therapy in Postmenopausal Osteoporosis

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Denosumab

Criteria

Inclusion Criteria:

• Postmenopausal women at high risk of fracture

Exclusion Criteria:

• Prior therapy exclusions

1. current use or use in the past 12 months of oral bisphosphonates or denosumab

2. current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin.

3. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months

4. any current or previous use of romosozumab, strontium, teriparatide, abaloparatide, or any parenteral bisphosphonate.

Other exclusions

1. Confirmed serum alkaline greater than 2 times the upper normal limit).

2. Stage 4 or 5 chronic kidney disease (GFR less than 30)

3. Hypercalcemia (Calcium greater than 10.5 mg/dL)

4. Hypocalcemia (Calcium less than 8.8 mg/dL)

5. Elevated blood parathyroid hormone (PTH) (intact PTH greater than 65 pg/ml)

6. Serum 25-hydroxy vitamin D less than 20 ng/ml

7. Hematocrit less than 32%.

8. History of malignancy (except basal cell carcinoma).

9. Significant pulmonary disease

10. History of myocardial infarction or stroke within the preceding year.

11. History of unstable angina or transient ischemic attack in the past year.

12. Current atrial fibrillation.

13. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.

14. Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.

15. Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.

16. Uncontrolled eczema

17. Congenital or acquired bone disease other than osteoporosis

18. Known sensitivity to denosumab or any of its excipients.

19. Known sensitivity to romosozumab or any of its excipients.