NCT05688969

Mechanisms of Anabolic Osteoporosis Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.

Detailed description

The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a randomized clinical trial testing the efficacy of a drug - the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
OTHER	early versus late biopsy	early (3-6 weeks) versus late (6-8 months) biopsy

Timeline

• Start date: 2023-06-14
• Primary completion: 2028-02-01
• Completion: 2028-12-01
• First posted: 2023-01-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States