Actively Recruiting
Mechanisms of Anabolic Osteoporosis Therapy
Led by Massachusetts General Hospital · Updated on 2025-12-18
16
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Mechanisms of Anabolic Osteoporosis Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged over 45 years
- Postmenopausal by either more than 36 months since last spontaneous menses or more than 36 months since hysterectomy plus serum FSH over 40 units/liter if under 60 years
- Prescribed romosozumab by treating physician
- Meet FDA-defined indication for romosozumab use in osteoporosis (high risk for fracture or intolerance/failure of other therapies)
- Not at increased risk for bone marrow aspirate or bone biopsy
You will not qualify if you...
- Renal disease stage 4 chronic kidney disease
- Elevated intact parathyroid hormone over 77 pg/ml
- Serum 25-OH vitamin D below 20 ng/ml
- Major psychiatric disease preventing informed consent or protocol completion
- Excessive alcohol use or substance abuse preventing informed consent or protocol completion
- Known congenital or acquired bone disease other than osteoporosis
- Exposure to oral bisphosphonates within past 3 months
- Exposure to denosumab within past 12 months
- Exposure to intravenous bisphosphonates within past 24 months
- Exposure to estrogens, selective estrogen receptor modulators, or calcitonin, or glucocorticoids for more than 14 days in past 2 months
- Any prior exposure to romosozumab
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mass General Brigham
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Mackenzie Jordan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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