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Can a bone drug help spinal fusion patients heal stronger?

NCT ID NCT03841058

Disease control Sponsor: Hospital for Special Surgery, New York 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether the bone-building drug abaloparatide (Tymlos) can improve healing after spinal fusion surgery. About 96 postmenopausal women and men aged 50+ will receive either the drug or a placebo daily for 6 months. Researchers will check bone fusion quality and pain levels up to one year after surgery.

What this could mean

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

Active substance
Abaloparatide (Tymlos)
What this could lead to
If it works, this could lead to a treatment that helps bones heal better and faster after spinal fusion surgery, reducing complications like screw loosening.
What could go wrong
This is a small, early-phase trial with only 96 participants, so results may not apply to everyone. The drug may not improve fusion outcomes or could cause side effects.

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.

Participants

About 96 people

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

Started

Aug 2019

Expected to finish

Feb 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

50 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: * Postmenopausal women (defined as \>12 months since last menstrual cycle) OR men * Age of 50 years or older * Requiring posterolateral lumbar spine fusion surgery (L1-2; L2-3; L3-4; L4-5, L5-S1) with single or multi-level fusion for degenerative conditions of the lumbar spine (including lumbar degenerative disk disease, severe instability, high grade spondylolisthesis, deformity, degenerative scoliosis, pseudoarthrosis, and spinal stenosis) under the care of spine surgeons at the Hospital for Special Surgery. Exclusion Criteria: 1. Hypersensitivity to abaloparatide 2. Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy 3. Patients with active hypercalcemia or current diagnosis of hyperparathyroidism 4. History of multiple renal calculi or renal calculus within 2 years 5. Unexplained elevations in alkaline phosphatase 6. Evidence of metastatic cancer or multiple myeloma. 7. Patients unwilling to take placebo or abaloparatide. 8. Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery 9. Chronic oral steroids (\>= 7.5 mg prednisone/d currently and for more than 1 month) for an inflammatory comorbid diagnosis 10. Patients who cannot understand and sign the informed consent 11. Patients who are unable to meet the proposed follow-up schedule 12. Patients with \>1 year of prior cumulative treatment with Forteo and/or Tymlos, or any use of Forteo or Tymlos within the 6 months prior to enrollment. 13. Patients who have received bisphosphonate treatment of \>1 year in past 5 years 14. Patients who are current smokers

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

Spinal fusion

Contacts and locations

Locations

  • Hospital for Special Surgery

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.