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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05010590
Other study ID # 2021P002125
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 24, 2022
Est. completion date May 1, 2024

Study information

Verified date May 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 50
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Romosozumab
Monthly romosozumab
Denosumab
Every 6 months denosumab

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total hip areal bone mineral density Change in total hip bone density between month 0 and month 12 Month 0 to 12
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