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Could a new dosing schedule supercharge bone strength?

NCT ID NCT06059222

Disease control Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study looks at whether giving the osteoporosis drug romosozumab in two separate 6-month blocks, with breaks for another drug called zoledronate, can build more bone than the standard 12-month course. It involves 270 postmenopausal women with osteoporosis and a recent fracture. The goal is to find the safest and most effective way to combine these medications.

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 zoledronate
What this could lead to
If successful, this could identify a more effective dosing schedule for romosozumab and zoledronate, leading to stronger bones and fewer fractures in women with osteoporosis.
What could go wrong
This is a phase 4 trial with 270 participants, so results may not apply to all patients. Different dosing schedules may not improve outcomes and could carry risks like bone pain or rare jaw problems.

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 270 people

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

Started

Oct 2023

Expected to finish

Aug 2032

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

50 years and older

Sex

Female participants only

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: * Postmenopausal women (postmenopausal for at least two years) * BMD T-score \< -2.5 at lumbar spine, total hip, or femoral neck * Osteoporotic fracture within the last 3 years at the spine, hip, pelvis, humerus or forearm after the age of 50 years. Exclusion Criteria: * Osteoporosis treatment including hormone replacement therapy within the last 5 years * Metabolic bone disease * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, liver dysfunction (baseline phosphatase higher than twice upper limit), rheumatism, severe COPD (chronic obstructive pulmonary disease), hypopituitarism, Cushing's disease * Ongoing treatment with glucocorticoids (systemic) * Estimated glomerular filtration rate (eGFR) \< 35 mL/min * Contraindications for zoledronate according to the Supplementary protection certificates (SPC) * Contraindications for romosozumab according to the SPC * For the subgroup with Jamshidi biopsies contraindications for local anaesthetics according to the SPC * For the subgroup with Jamshidi biopsies contraindications for tetracycline or doxycykline according to the SPC

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Conditions

The condition(s) this trial relates to.

osteoporosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoporosis

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

  • Department of Endrocinology and Internal Medicine

    RECRUITING

    Aarhus, 8000, Denmark

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