Overview
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 investigators will randomize volunteers to either the early or late second biopsy.
Eligibility
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 > 45 years
2. Postmenopausal by either of the following criteria:
1. > 36 since last spontaneous menses
2. > 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.