Anabolic Therapy in Postmenopausal Osteoporosis

NCT ID: NCT05010590

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2027-11-01

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.

Conditions

Postmenopausal Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Romosozumab and denosumab

Group Type: ACTIVE_COMPARATOR

Romosozumab

Intervention Type: DRUG

Monthly romosozumab

Denosumab

Intervention Type: DRUG

Every 6 months denosumab

Romosozumab

Group Type: ACTIVE_COMPARATOR

Romosozumab

Intervention Type: DRUG

Monthly romosozumab

Interventions

Romosozumab

Monthly romosozumab

Intervention Type: DRUG

Denosumab

Every 6 months denosumab

Intervention Type: DRUG

Eligibility 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, 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Benjamin Leder, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Leder, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P002125

Identifier Type: -

Identifier Source: org_study_id