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Osteoporosis drug studied for spine surgery recovery – but trial pulled

NCT ID NCT06973109

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

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study aimed to see if romosozumab (Evenity) could improve bone density and muscle mass in postmenopausal women with osteoporosis undergoing lumbar spine surgery. Participants would have received monthly injections of romosozumab or weekly alendronate pills for 12 months. However, the trial was withdrawn before any volunteers enrolled, so no data were collected.

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)
What this could lead to
If it worked, romosozumab could improve bone density and muscle mass, potentially reducing complications and aiding recovery after spine surgery in women with osteoporosis.
What could go wrong
The trial was withdrawn before enrolling any participants, so no results are available. Even if conducted, it was a small Phase 2 study, and benefits may not be confirmed in larger trials.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

65 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: * Post-menopausal female * Diagnosed with osteoporosis (T-score ≤ -2.5). * Scheduled for or planning posterior lumbar fusion for degenerative disease, at least 3 months in the future. * Able to provide informed consent. Exclusion Criteria: * History of prior spinal surgery. * Male sex. * Current or prior use of osteoporosis medications within the past 3 years. * Current use of anabolic agents other than romosozumab. * Current use of androgen receptor (AR) modulators, such as testosterone replacement therapy or selective androgen receptor modulators (SARMs). * Severe renal impairment (eGFR \< 30 mL/min/1.73m²). * Known hypersensitivity to romosozumab, alendronate or zoledronic acid. * Severe spinal deformity. * Active malignancy or history of malignancy within the past 5 years. * Any secondary cause of decreased BMD (e.g., hyperparathyroidism). * Stroke or myocardial infarction in the past year. * Planned fusion involving more than 4 levels. * Uncorrected hypocalcemia and/or hypovitaminosis D * Esophageal abnormalities

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Conditions

The condition(s) this trial relates to.

osteoporosis postmenopausal osteoporosis

As listed by the trial registrant

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

Osteoporosis, post-menopausal

Contacts and locations

Locations

  • University of Pittsburgh Medical Center (UPMC) - Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213, United States

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