Anabolic Therapy in Postmenopausal Osteoporosis

Postmenopausal Osteoporosis Clinical Trial

Official title:

Anabolic Therapy in Postmenopausal Osteoporosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05010590
• Other study ID #: 2021P002125
• Status: Active, not recruiting
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

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