Anabolic Therapy in Postmenopausal Osteoporosis
Running, not enrolling · Phase 4
Conditions studied: Postmenopausal Osteoporosis
In brief
In this research study we want to learn more about the effect of two different FDA-approved medications in the treatment of osteoporosis.
Key facts
- Study ID
- NCT05010590
- Run by
- Massachusetts General Hospital
- People needed
- 50
- Starts
- 2022-03-24
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 45 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Postmenopausal women at high risk of fracture
You may not qualify if…
- Prior therapy exclusions
- current use or use in the past 12 months of oral bisphosphonates or denosumab
- current use or use within the past 3 months of estrogens, SERMs, or calcitonin.
- use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
- any current or previous use of romosozumab or strontium
- current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate.
- Other exclusions
- Confirmed serum alkaline greater than 2 times the upper normal limit.
- Stage 4 or 5 chronic kidney disease (GFR less than 30)
- Hypercalcemia (Ca greater than 10.5 mg/dL)
- Hypocalcemia (Ca less than 8.8 mg/dL)
- Elevated blood PTH (intact PTH greater than 77 pg/mL)
- Serum 25-OH vitamin D less than 20 ng/mL
- HCT less than 32%.
- History of malignancy (except basal cell carcinoma).
- Significant pulmonary disease
- History of myocardial infarction or stroke within the preceding year.
- History of unstable angina or transient ischemic attack in the past year.
- Current atrial fibrillation.
- Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events.
- 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 in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
- Uncontrolled eczema
- Congenital or acquired bone disease other than osteoporosis.
- Known sensitivity to denosumab or any of its excipients.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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