Mechanisms of Anabolic Osteoporosis Therapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

∙ All postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are not at increased risk for a bone marrow aspirate or bone biopsy will be offered enrollment. The FDA approved indication for romosozumab is: the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. Volunteers must be:

• Female aged \> 45 years

• Postmenopausal by either of the following criteria:

‣ \> 36 since last spontaneous menses

⁃ \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years

Locations
United States
Massachusetts
Mass General Brigham
RECRUITING
Boston
Contact Information
Primary
Mackenzie Jordan
MRJORDAN@mgh.harvard.edu
617-726-6129
Time Frame
Start Date: 2023-06-14
Estimated Completion Date: 2028-12
Participants
Target number of participants: 16
Treatments
Active_comparator: Early Biopsy
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 clinical trial: 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.
Active_comparator: Late Biopsy
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 clinical trial: 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.
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov