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New drug combo may protect bones after spinal cord injury

NCT ID NCT05101018

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 4 trial tests whether starting with romosozumab for 12 months and then switching to denosumab for another 12 months can better maintain bone density around the knee in people with recent spinal cord injury, compared to using denosumab alone. The study involves 40 adults aged 18-55 who have had a spinal cord injury for less than 6 months. Researchers will measure bone mineral density using X-ray scans to see which approach works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Romosozumab (Evenity) and Denosumab (Prolia)
What this could lead to
If successful, this could point toward a better treatment sequence to prevent severe bone loss and fractures after spinal cord injury.
What could go wrong
This is a small early-phase trial with only 40 participants, so results may not apply to everyone. Romosozumab carries heart risks, and the study excludes people with heart disease or stroke history.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Traumatic motor-complete or incomplete SCI C4-L2 (AIS grade A-C); 2. Duration of SCI less than 6 months; 3. Males and females (premenopausal) between the ages of 18 and 55 years old; and a safe range of BMD right above the knee as determined by study staff review; Exclusion Criteria: 1. Active and/or history of coronary heart disease or stroke; 2. Bone cancer; 3. Long-bone fracture of the leg within the past year; 4. History of prior bone disease (for example, Paget's hyperparathyroidism, osteoporosis, etc.); 5. Postmenopausal women; 6. Men with known low functioning tests before SCI; 7. Drugs geared toward increasing BMD longer than a six month duration after SCI; 8. As determined by study staff review of my medication history of glucocorticoid administration longer than three months duration within the last year 9. Abnormalities of my endocrine glands such as hyperthyroidism, Cushing's disease or syndrome, etc.; 10. Severe underlying chronic disease (for example chronic obstructive pulmonary disease (COPD), end-stage heart disease, chronic renal failure); 11. Heterotopic ossification (HO) of the distal femur (the knee end of the thigh bone). HO is a condition where bone tissue forms outside of the skeleton. If HO is found in any other area than the distal femur it will not prevent my participation in the study.; 12. History of chronic alcohol abuse; 13. Diagnosis of hypercalcemia (high levels of calcium in the blood); 14. Pregnancy; 15. As determined by study staff review of my medications a bisphosphonate for heterotopic ossification (HO), or other medications to treat osteoporosis other than calcium and vitamin D; 16. Current diagnosis of cancer or history of cancer; 17. As determined by study staff review of my medications, prescribed moderate or high dose corticosteroids (\>40 mg/d prednisone or an equivalent dose of other corticosteroid medication) for longer than one week, not including drug administered to preserve neurological function at the time of acute SCI; and 18. Life expectancy less than 5 years.

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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

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468, United States

  • Kessler Institute for Rehabilitation

    West Orange, New Jersey, 07052, United States

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