Bone battle: which osteoporosis drug wins?
NCT ID NCT05010590
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study compares two FDA-approved medications, romosozumab and denosumab, for treating postmenopausal osteoporosis. Researchers will measure changes in hip bone density over 12 months in 50 women at high fracture risk. The goal is to see which drug works better to strengthen bones.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Romosozumab and Denosumab
- What this could lead to
- If successful, this study could show which medication is better at increasing bone density and reducing fracture risk in postmenopausal women.
- What could go wrong
- This is a small, early-phase trial with only 50 participants, so results may not apply to all women. Both drugs have known side effects like joint pain or rare bone issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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50 people
The number who actually took part.
- Started
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Mar 2022
- Expected to finish
-
Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Postmenopausal women at high risk of fracture Exclusion Criteria: * Prior therapy exclusions 1. current use or use in the past 12 months of oral bisphosphonates or denosumab 2. current use or use within the past 3 months of estrogens, SERMs, or calcitonin. 3. use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months 4. any current or previous use of romosozumab or strontium 5. current use or use within the past 3 years of teriparatide, abaloparatide, or any parenteral bisphosphonate. Other exclusions 1. Confirmed serum alkaline greater than 2 times the upper normal limit. 2. Stage 4 or 5 chronic kidney disease (GFR less than 30) 3. Hypercalcemia (Ca greater than 10.5 mg/dL) 4. Hypocalcemia (Ca less than 8.8 mg/dL) 5. Elevated blood PTH (intact PTH greater than 77 pg/mL) 6. Serum 25-OH vitamin D less than 20 ng/mL 7. HCT less than 32%. 8. History of malignancy (except basal cell carcinoma). 9. Significant pulmonary disease 10. History of myocardial infarction or stroke within the preceding year. 11. History of unstable angina or transient ischemic attack in the past year. 12. Current atrial fibrillation. 13. Any health condition that, in the opinion of the study physician, significantly increases the risk of cardiovascular events. 14. Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. 15. 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. 16. Uncontrolled eczema 17. Congenital or acquired bone disease other than osteoporosis. 18. Known sensitivity to denosumab or any of its excipients. 19. Known sensitivity to romosozumab or any of its excipients. 20. History of osteonecrosis of the jaw, extensive dental work involving extraction or dental implants in the past 3 months, or extensive dental work planned in the upcoming 12 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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