Bone battle: which osteoporosis drug wins?

NCT ID NCT05010590

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

50 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

45 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

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