Postmenopausal Osteoporosis
Conditions
Brief summary
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
Interventions
DRUGRomosozumab
Monthly romosozumab
DRUGDenosumab
Every 6 months denosumab
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes
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, SERMs, 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 or strontium 5. current use or use within the past 3 years of 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 (Ca greater than 10.5 mg/dL) 4. Hypocalcemia (Ca less than 8.8 mg/dL) 5. Elevated blood PTH (intact PTH greater than 77 pg/mL) 6. Serum 25-OH vitamin D less than 20 ng/mL 7. HCT 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. 20. History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total hip areal bone mineral density | Month 0 to 12 | Change in total hip bone density between month 0 and month 12 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Leder, MD
Massachusetts General Hospital
Outcome results
None listed