Studies how bone cells respond during early and late phases of osteoporosis treatment
Studies bone cell changes during early and late treatment in postmenopausal women with osteoporosis.
Plain-language title generated from the registry record
Registry title: Mechanisms of Anabolic Osteoporosis Therapy
Key facts
- Where
- Boston, United StatesSee the site
Where in United States
- Mass General BrighamBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT05688969
- Record updated
- 18 December 2025
- Original description
The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.Read full original descriptionShow less
Mechanisms of Anabolic Osteoporosis Therapy
The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.
Inclusion: 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: any prior exposure to romosozumab; renal disease (stage 4 CKD); major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures; known congenital or acquired bone disease other than osteoporosis; serum 25-OH vitamin D < 20 ng/ml; elevated blood PTH (intact PTH > 77 pg/ml); excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures; 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.