Trauma InjuryPhase 3NCT05516849
Placebo Versus Oxandrolone Supplementation in Trauma
A Phase 3 study testing Oxandrolone in people with Trauma Injury, run by Sunnybrook Health Sciences Centre.
Trial summary
The primary aim of this study is to examine the effect of Oxandrolone supplementation after lower extremity high energy fracture on muscle volume recovery. As Oxandrolone supplementation has never been examined in this patient population, the primary null hypothesis is that there will be no difference in measured… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Oxandrolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2022to 3 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- Ages 18-55 [inclusive]
- Skeletally-mature as based upon tibial or femoral physeal closure41
- Fracture of the femur or tibia treated with open reduction and internal fixation (simple articular patterns allowed).
- High energy injuries with associated local soft tissue damage. -
Who cannot join
- Unable to participate in rehabilitation including severe head injury, pre-existing TBI or cognitive dysfunction (stroke, dementia, documented developmental delay), patients with significant spinal cord injury or pre-accident paralytic injury or condition will beessential treatment in both intervention and control groups.
- Medically unfit for anabolic steroid treatment including those with active malignancy, concurrent prednisone use, elevated liver enzymes at baseline (baseline bloodwork to include LFT)
- Fracture due to primary or metastatic bone lesion
- Any contraindications to MRI.
- Patients with major psychiatric illness [trauma presentation for suicide attempts] and incarcerated patients will be excluded as they may lack autonomy, decision-making capacity and the ability to meet follow-ups.
- Patients with substance use disorders, due to increased abuse potential and possible baseline hepatic injury.
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- Patients who are on blood thinning medication, at baseline.
- Patients receiving hormone treatment.
- Patients with active cancers.
- Patients with a history of hypercalcemia/parathyroid disease and chronic renal disease.
- -
About this study
Official title: Placebo Versus Oxandrolone Supplementation in Trauma: A Randomized Multi-Center Double Blind Clinical Trial in High-Energy Lower Extremity Trauma (POST-Injury Trial)
The primary aim of this study is to examine the effect of Oxandrolone supplementation after lower extremity high energy fracture on muscle volume recovery. As Oxandrolone supplementation has never been examined in this patient population, the primary null hypothesis is that there will be no difference in measured thigh muscle mass volume between Oxandrolone supplementation and placebo administration groups.
Read the detailed description
Lower extremity fractures associated with high-energy mechanisms of injury (combat injuries including blast or crush injuries, motor vehicle accidents, fall from significant height, gunshot injuries) are unfortunately common among active service members and civilians presenting to level-1 trauma centers worldwide. High-energy fractures have several unique characteristics that distinguish them from low-energy injuries. They typically occur in predominately younger, male patients (30-65 years old)1 and involve significant soft-tissue stripping or damage. These patients require at least one major reconstructive surgery, with the majority requiring multiple reconstructive surgeries, each associated with additional soft tissue injury and subsequent prolonged immobilization to facilitate limb stabilization. Despite extended rehabilitation focused on neuromuscular retraining and muscular development, the result is often permanent limitations of ambulation and medical retirement from active duty due to volumetric muscle loss. So, while advances in orthopedic approaches to fracture care have lowered complications such as non-union and malunion, rendering them less significant as limitations to restoring function soft-tissue complications now predominate.
Oxandrolone has been successfully utilized to accelerate muscular recovery, reduce muscle loss, and improve function in several populations including healthy elderly patients with frailty/sarcopenia, patients with large surface area burns, neuromuscular diseases, HIV, congenital heart disease and genetic diseases including Klinefelter's and Turner's Syndromes. In addition, Oxandrolone has also been safely used in pediatric patients to treat constitutionally delayed growth. Given the similarities in patient populations and the known limitations of volumetric muscle loss in military personnel and civilians after major trauma, Oxandrolone supplementation may reduce initial volumetric muscle loss and improve long-term muscle mass and function.
- Conditions
- Trauma Injury
- Being tested
- Oxandrolone, Placebo
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxandroloneDrug
Oxandrolone is a synthetic anabolic androgenic steroid that induces its responses by binding to androgen receptors which modulates gene expression to increase protein synthesis and efficient utilisation of amino acids. Oxandrolone was first synthesized in 1962 through 17alpha-alkylation of testosterone resulting in a formal composition of (4bS,7S,9aS,9bR,11aS)-tetradecahydro-7-hydroxy-4aS,6aS,7-trimethyl- cyclopentanaphthopyran-2(1H)-one and molecular formula of C19H30O3.
PlaceboOther
As there is currently no approved medication to aid in soft-tissue regeneration, we will be using a placebo control.
| Study group | Role | What they receive |
|---|---|---|
| Oxandrolone | Experimental | Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using the REDCap database randomization procedure. Receives: Drug: Oxandrolone |
| Placebo | Placebo comparator | Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using the REDCap database randomization procedure. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta volumetric vastus medialis diameter on MRI
MRI is taken to assess the vastus medialis muscle mass.
Measured: upto 6 months
Secondary outcomes (10)
Delta volumetric thigh muscle mass on MRI
Delta volumetric thigh muscle mass on MRI at 52 week Post treatment and the VMO (Vastus Medialis) at 26 week visit.
Measured: Up to 1 year
Functional measure: 6-minute walk test
Measured: Up to 1 year
Activity count by ActiGraph GT3X-BT
The actigraph measures sleep efficiency.
Measured: Up to 1 year
Short Form 36 Health Survey
The minimum score is 0, and maximum score is 5.
Measured: Up to 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)
The minimum score is 0, and maximum score is 10.
Measured: Up to 1 year
Standard AP and Lateral X-Rays
Time to radiographic union of fracture in weeks based on bridging callous of 3 of 4 cortices on standard AP and lateral x-rays
Measured: Through study completion, an average of 1 year
Length of in-patient Acute Hospital stay, and Rehabilitation stay
Length of in-patient Acute Hospital stay, and Rehabilitation stay to be determined by the orthopedic surgeon.
Measured: Through study completion, an average of 1 year
MARX Scale
The minimum score is 0, and maximum score is 10.
Measured: Up to 1 year
VAS Score
The minimum score is 0, and maximum score is 10.
Measured: Up to 1 year
Hand-Held Dynamometer
The hand-held dynamometer is a small device that fits in the examiner's hand and is placed at precise locations on a subject's limb in an effort to assess the force generated by various muscles or groups of muscles.The minimum score is 0, and maximum score is 10.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start19 May 2022 (estimated)
- Primary completion3 Aug 2023 (estimated)
- Study completion3 Aug 2023 (estimated)
Why it stopped: FDA requested manufacturers of Oxandrolone Tablets, to voluntarily remove previously approved drug applications for Oxandrolone from the U.S. market \& the funding decided to prematurely terminate the funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using a minimal sufficient randomization technique in REDCAP.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516849
- Sponsor's protocol ID
- 3822: POST-INJURY
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Versus Oxandrolone Supplementation in Trauma: A Randomized Multi-Center Double Blind Clinical Trial in High-Energy Lower Extremity Trauma (POST-Injury Trial)
- ClinicalTrials.gov ID
- NCT05516849
- Acronym / sponsor ID
- 3822: POST-INJURY
- Conditions
- Trauma Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA requested manufacturers of Oxandrolone Tablets, to voluntarily remove previously approved drug applications for Oxandrolone from the U.S. market \& the funding decided to prematurely terminate the funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- United States Department of Defense, Walter Reed National Military Medical Center
- Study start
- 19 May 2022 (estimated)
- Primary completion
- 3 Aug 2023 (estimated)
- Study completion
- 3 Aug 2023 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to examine the effect of Oxandrolone supplementation after lower extremity high energy fracture on muscle volume recovery. As Oxandrolone supplementation has never been examined in this patient population, the primary null hypothesis is that there will be no difference in measured thigh muscle mass volume between Oxandrolone supplementation and placebo administration groups.
Detailed description
Lower extremity fractures associated with high-energy mechanisms of injury (combat injuries including blast or crush injuries, motor vehicle accidents, fall from significant height, gunshot injuries) are unfortunately common among active service members and civilians presenting to level-1 trauma centers worldwide. High-energy fractures have several unique characteristics that distinguish them from low-energy injuries. They typically occur in predominately younger, male patients (30-65 years old)1 and involve significant soft-tissue stripping or damage. These patients require at least one major reconstructive surgery, with the majority requiring multiple reconstructive surgeries, each associated with additional soft tissue injury and subsequent prolonged immobilization to facilitate limb stabilization. Despite extended rehabilitation focused on neuromuscular retraining and muscular development, the result is often permanent limitations of ambulation and medical retirement from active duty due to volumetric muscle loss. So, while advances in orthopedic approaches to fracture care have lowered complications such as non-union and malunion, rendering them less significant as limitations to restoring function soft-tissue complications now predominate.
Oxandrolone has been successfully utilized to accelerate muscular recovery, reduce muscle loss, and improve function in several populations including healthy elderly patients with frailty/sarcopenia, patients with large surface area burns, neuromuscular diseases, HIV, congenital heart disease and genetic diseases including Klinefelter's and Turner's Syndromes. In addition, Oxandrolone has also been safely used in pediatric patients to treat constitutionally delayed growth. Given the similarities in patient populations and the known limitations of volumetric muscle loss in military personnel and civilians after major trauma, Oxandrolone supplementation may reduce initial volumetric muscle loss and improve long-term muscle mass and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using a minimal sufficient randomization technique in REDCAP.
| Arm | Type | Receives |
|---|---|---|
| Oxandrolone | Experimental | Drug: OxandroloneParticipants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using the REDCap database randomization procedure. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using the REDCap database randomization procedure. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Ages 18-55 [inclusive]
- Skeletally-mature as based upon tibial or femoral physeal closure41
- Fracture of the femur or tibia treated with open reduction and internal fixation (simple articular patterns allowed).
- High energy injuries with associated local soft tissue damage. -
Key exclusion criteria (11 listed)
- Unable to participate in rehabilitation including severe head injury, pre-existing TBI or cognitive dysfunction (stroke, dementia, documented developmental delay), patients with significant spinal cord injury or pre-accident paralytic injury or condition will beessential treatment in both intervention and control groups.
- Medically unfit for anabolic steroid treatment including those with active malignancy, concurrent prednisone use, elevated liver enzymes at baseline (baseline bloodwork to include LFT)
- Fracture due to primary or metastatic bone lesion
- Any contraindications to MRI.
- Patients with major psychiatric illness [trauma presentation for suicide attempts] and incarcerated patients will be excluded as they may lack autonomy, decision-making capacity and the ability to meet follow-ups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxandroloneOxandrolone is a synthetic anabolic androgenic steroid that induces its responses by binding to androgen receptors which modulates gene expression to increase protein synthesis and efficient utilisation of amino acids. Oxandrolone was first synthesized in 1962 through 17alpha-alkylation of testosterone resulting in a formal composition of (4bS,7S,9aS,9bR,11aS)-tetradecahydro-7-hydroxy-4aS,6aS,7-trimethyl- cyclopentanaphthopyran-2(1H)-one and molecular formula of C19H30O3. | Drug | Oxandrolone |
| PlaceboAs there is currently no approved medication to aid in soft-tissue regeneration, we will be using a placebo control. | Other | Placebo |
Primary outcome
Delta volumetric vastus medialis diameter on MRI
Time frame: upto 6 months
MRI is taken to assess the vastus medialis muscle mass.
10 secondary outcomes
Delta volumetric thigh muscle mass on MRI
Time frame: Up to 1 year
Functional measure: 6-minute walk test
Time frame: Up to 1 year
Activity count by ActiGraph GT3X-BT
Time frame: Up to 1 year
Short Form 36 Health Survey
Time frame: Up to 1 year
Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: Up to 1 year
Standard AP and Lateral X-Rays
Time frame: Through study completion, an average of 1 year
Length of in-patient Acute Hospital stay, and Rehabilitation stay
Time frame: Through study completion, an average of 1 year
MARX Scale
Time frame: Up to 1 year
VAS Score
Time frame: Up to 1 year
Hand-Held Dynamometer
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxandrolone in people with Trauma Injury, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta volumetric vastus medialis diameter on MRI (time frame: upto 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.