Could a muscle hormone shield bones after spinal cord injury?

NCT ID NCT05319522

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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 This study
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 Results may not be published yet.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

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

Researchers are studying whether a muscle-released hormone called irisin is linked to bone strength in people with spinal cord injury. They will compare irisin levels and bone density between individuals with spinal cord injury and healthy controls. Participants will also do one session of high-intensity arm cycling to see if exercise can raise irisin levels. The goal is to understand whether boosting irisin through exercise might help prevent fractures.

What this could mean

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

Active substance
Acute high-intensity interval arm ergometer exercise
What this could lead to
If irisin helps maintain bone, this could point toward exercise-based ways to lower fracture risk in people with spinal cord injury.
What could go wrong
This is a small, early study with 11 participants, so results may not apply broadly. Exercise may not raise irisin enough to affect bone.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11 people

The number who actually took part.

Started

May 2023

Finished

Apr 2025

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Participants with SCI: * age 18 years or older * traumatic SCI at the cervical level 4 or lower that occurred at least 12 months prior to the start of the study * American Spinal Injury Association Impairment Scale A, B or C * uses a manual wheelchair as primary means of mobility (30+ hours per week) * is able to perform a transfer independently to and from a wheelchair * has adequate strength and upper extremity function to operate an arm ergometer Control Participants: * age and sex-matched to participant with SCI Exclusion Criteria: Participants with SCI: * active use of medications which potentially affect bone metabolism, including: parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates, oral glucocorticoids (use for more than 3 months) * history of fractures or dislocations in the upper extremity from which the participant has not fully recovered * upper limb pain or injury that interferes with the ability to perform aerobic exercise * recent hospitalization for any reason (within the past three months) * history of coronary artery disease, coronary bypass surgery or other cardiorespiratory events or conditions * likely to experience clinically significant autonomic dysreflexia and/ or orthostatic hypotension in response to vigorous exercise * endocrinopathy or metabolic disorders of the bone * e.g. Paget's disease, renal bone disease * history of allergic reaction to lidocaine * any other conditions that the person's primary care physician deems is a contraindication to participation in arm ergometry exercise stress testing or vigorous exercise * pregnant * participation in another "Greater than Minimal Risk" study. Control Participants: * active use of medications which potentially affect bone metabolism, including: parathyroid hormone and analogs, androgenic or estrogenic steroids, bisphosphonates, oral glucocorticoids (use for more than 3 months) * history of neuromuscular conditions which could influence muscle gene expression * history of lower body musculoskeletal injuries from which the participant has not fully recovered * recent hospitalization for any reason (within the past three months) * history of allergic reaction to lidocaine * any other conditions that the person's primary care physician deems is a contraindication to the performance of a vastus lateralis muscle biopsy * pregnant * participation in another "Greater than Minimal Risk" study

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Conditions

The condition(s) this trial relates to.

Motor Activity spinal cord injury

As listed by the trial registrant

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

Contacts and locations

Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240, United States

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