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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears

NCTNCT02420353 (opens ClinicalTrials.gov in a new tab)Other idHUM00087702Other idIND Exemption 123189
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
20 participants (actual)
Sponsor
University of Michigan · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
May 2015
Primary completion
Oct 2018
Completion
Oct 2018
First posted
17 Apr 2015 (estimated)
Last update posted
6 Jan 2020
Conditions
Rupture of Anterior Cruciate Ligament

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 2

    Evaluation of rGH Therapy to Prevent Muscle Atrophy in Patients With ACL Tears

    NCT02420353

    May 2015 to Oct 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Anterior cruciate ligament (ACL) tears are among the most frequent traumatic knee injuries that occur in physically active individuals. Despite advances in minimally invasive surgical reconstruction techniques and aggressive rehabilitation, this atrophy and loss of strength can persist even after patients return to full activity and can place them at considerable risk for re-injury and developing osteoarthritis (OA). The design of new therapeutic interventions to prevent muscle atrophy is needed to advance the care of patients who suffer from ACL injuries. The growth hormone (GH)/insulin-like growth factor-1 (IGF-1) axis plays an important role in promoting muscle growth and protecting muscle from atrophy. While GH therapy has shown promise in protecting immobilized muscle from various models of disuse atrophy, it remains unknown whether GH can help to restore strength and protect against the loss in strength that occurs after ACL tear. GH therapy may help to accelerate the safe return to play of patients that suffer ACL tears, and help to prevent the long-term OA and reduction in quality of life that occur after these traumatic knee injuries.

Interventions

  • SomatropinDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Somatropin

    Somatropin of rDNA origin

  • Placebo comparator

    Placebo

    A placebo vehicle that contains somatropin diluent but no active hormone.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op

    Time frame · at 26 wks post-op

    Registry description

    Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

Secondary outcomes(20)

  1. Normative Isokinetic Extension (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  2. Normative Isokinetic Flexion (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  3. Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  4. Normative Isometric Extension (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  5. Normative Isometric Extension (Nm) at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  6. Normative Isometric Flexion (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  7. Normative Isometric Flexion (Nm) at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Normalized values were calculated by dividing the value from the injured limb by the value from the contralateral, uninjured leg prior to surgery. For each measurement, the highest force from a series of 5 repetitions was used.

  8. Absolute Isokinetic Extension (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

  9. Absolute Isokinetic Extension (Nm) at 26 wk Post-op

    Time frame · at 26 wk post-op

    Registry description

    Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

  10. Absolute Isokinetic Flexion (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

  11. Absolute Isokinetic Flexion (Nm) at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    Absolute Isokinetic knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isokinetic measurements were performed at a speed of 60º/sec from a range of 0º to 90º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

  12. Absolute Isometric Extension (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

  13. Absolute Isometric Extension (Nm) at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

  14. Absolute Isometric Flexion (Nm) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. For each measurement, the highest force from a series of 5 repetitions was used.

  15. Absolute Isometric Flexion (Nm) at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    Absolute Isometric knee flexion and extension strength measurements were obtained in a System 3 dynamometer (BioDex, Shirley, New York). Isometric measurements were performed at 45º of knee flexion. Strength values were calculated by comparing the affected limb of each subject across study group. For each measurement, the highest force from a series of 5 repetitions was used.

  16. VR12 Health Survey: Physical Health Summary Measure Score at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.

  17. VR12 Health Survey: Physical Health Summary Measure Score at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed PCS maximum: 72.11; minimum: 0.59.

  18. VR12 Health Survey: Mental Health Summary Measure Score at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.

  19. VR12 Health Survey: Mental Health Summary Measure Score at 26 Weeks Post-op

    Time frame · at 26 weeks post-op

    Registry description

    The VR-12 includes 12 questions that do not give an overall score but yield a physical and mental component score. PCS and MCS summary scores are standardized using a t-score transformation and normalized to the U.S. population of a score of 50 and a standard deviation of 10. Higher PCS and MCS scores indicate better health. Medical Expenditure Panel Survey (MEPS) collected between 2000 and 2002 standard norms range as followed MCS Maximum: 76.09; Minimum: -2.47.

  20. International Knee Document Committee (IKDC) at Pre-op (Baseline)

    Time frame · at pre-op (baseline)

    Registry description

    The IKDC percentage score is a subjective patients reported outcome measure (PROM) that scores a participants over all score. The PROM looks at 3 categories: symptoms, sports activity, and knee function. Scores range from 0 to 100, the final score given is interpreted as a measure of function with higher scores representing higher levels of function.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· at 26 wks post-op

Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op

GroupValue (Nm)
Somatropin0.881
Placebo0.681
Secondary and other outcome results(7)
Secondary outcomeMean· at pre-op (baseline)

Normative Isokinetic Extension (Nm) at Pre-op (Baseline)

GroupValue (Nm)
Somatropin0.746
Placebo0.816
Secondary outcomeMean· at pre-op (baseline)

Normative Isokinetic Flexion (Nm) at Pre-op (Baseline)

GroupValue (Nm)
Somatropin0.738
Placebo0.92
Secondary outcomeMean· at 26 weeks post-op

Normative Isokinetic Flexion (Nm) at 26 Weeks Post-op

GroupValue (Nm)
Somatropin1.068
Placebo1.028
Secondary outcomeMean· at pre-op (baseline)

Normative Isometric Extension (Nm) at Pre-op (Baseline)

GroupValue (Nm)
Somatropin0.761
Placebo0.778
Secondary outcomeMean· at 26 weeks post-op

Normative Isometric Extension (Nm) at 26 Weeks Post-op

GroupValue (Nm)
Somatropin0.718
Placebo0.633
Secondary outcomeMean· at pre-op (baseline)

Normative Isometric Flexion (Nm) at Pre-op (Baseline)

GroupValue (Nm)
Somatropin0.771
Placebo0.867
Secondary outcomeMean· at 26 weeks post-op

Normative Isometric Flexion (Nm) at 26 Weeks Post-op

GroupValue (Nm)
Somatropin1.017
Placebo0.954

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
SomatropinSomatropin of rDNA origin Somatropin: GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.0 / 100 / 105 / 10
PlaceboA placebo vehicle that contains somatropin diluent but no active hormone. Placebo: A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.0 / 90 / 95 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2020

The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.

Mendias et al. 2020The American journal of sports medicinecited by 18

PMID 32452208PMC7351248DOI 10.1177/0363546520920591PUB-32452208

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years up to 35 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Males between the ages of 18 and 35 * Have acute unilateral complete ACL tears with or without bucket handle medial meniscus tears that occurred within the past 6 months * Consent to undergo an ACL reconstruction by an orthopaedic surgeon using a patellar tendon or hamstring autograft * Will be performing supervised post-operative rehabilitation at UMHS MedSport at Dominos Farms Exclusion Criteria: * Patients who are undergoing a revision ACL reconstruction * Had a previous injury to the involved knee * Have an allergy to recombinant GH * Have a BMI\<20 or \>35 * Have a growth disorder of bones or connective tissue, type 1 diabetes mellitus, type 2 diabetes mellitus, or who have a history of carpal tunnel syndrome, trigger finger, myopathy, cancer, endocrine disorder, hypertension or rheumatologic disorder. * Systolic blood pressure \>140mm Hg or diastolic blood pressure \>90mm Hg, or with resting heart rate \>110 BPM or \<40 BPM at screening. * Additionally, because GH is currently listed as a banned substance by the World Anti-Doping Agency (WADA), National Collegiate Athletics Association (NCAA) and most professional sports agencies, we will exclude patients who are current collegiate, professional or elite athletes.

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