Mechanisms of Anabolic Osteoporosis Therapy
Recruiting · NCT05688969 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
early versus late biopsy
What this trial is about
The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
Who can take part
Age range
45 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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:
- 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
Exclusion criteria
- renal disease (stage 4 CKD)
- elevated blood PTH (intact PTH \> 77 pg/ml).
- serum 25-OH vitamin D \< 20 ng/ml
- major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- known congenital or acquired bone disease other than osteoporosis.
- exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months.
- exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months.
- any prior exposure to romosozumab.
Where it is running
1 location listed across 1 US state.
- Mass General Brigham - Boston, Massachusetts, United States