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Can a One-Year bone drug switch beat standard therapy for Steroid-Induced bone loss?

NCT ID NCT07757373

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This study follows people with bone loss caused by long-term steroid use to compare two treatment approaches. One group received romosozumab for the first year and then switched to denosumab, while the other group took denosumab throughout. After six years, researchers will measure bone mineral density to see which strategy better preserves bone strength.

What this could mean

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

Active substance
Romosozumab followed by denosumab, compared with denosumab alone
What this could lead to
If successful, this could show which treatment sequence better preserves bone density over the long term for people on chronic steroids, potentially guiding safer osteoporosis care.
What could go wrong
This is a small, extended observation of an earlier trial, not a fresh large study. Results may not apply broadly, and bone density changes do not guarantee fewer fractures.

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 54 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 years and older

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: \- patients who are continued on 6-monthly subcutaneous injection of DEN in either the ROMO or DEN arms after month 48; (2) those who are willing to have a repeat DXA assessment at the end of 6 years Exclusion Criteria: * patients who refuse to be maintained on denosumab after month 48 * patients who are maintained on other anti-osteoporotic drugs after month 48 * patients in whom prednisolone is planned to be tapered or discontinued after month 48.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tuen Mun Hospital

    Hong Kong, Hong Kong