Mechanisms of Anabolic Osteoporosis Therapy
Massachusetts General Hospital
Summary
The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
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 investiga…
Eligibility
- Age range
- 45+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 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: 1. Female aged…
Interventions
- Otherearly versus late biopsy
early (3-6 weeks) versus late (6-8 months) biopsy
Location
- Mass General BrighamBoston, Massachusetts