Anabolic Therapy in Postmenopausal Osteoporosis

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05010590
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 25.3
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Osteoporosis	Drug: Romosozumab; Drug: Denosumab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Anabolic Therapy in Postmenopausal Osteoporosis
• Actual Study Start Date: Mar 24, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Romosozumab and denosumab	Drug: Romosozumab; Monthly romosozumab; Drug: Denosumab; Every 6 months denosumab
Active Comparator: Romosozumab	Drug: Romosozumab; Monthly romosozumab

Outcome Measures

Primary Outcome Measures

1. Total hip areal bone mineral density [Month 0 to 12]

   Change in total hip bone density between month 0 and month 12

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Benjamin Leder, MD, Mass. General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT05010590
• Other Study ID Numbers: 2021P002125
• First Posted: Aug 18, 2021
• Last Update Posted: Jul 15, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Denosumab

Study Results

No Results Posted as of Jul 15, 2022