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

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ClinicalTrials.gov Identifier: NCT02420353
Recruitment Status : Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Mendias, PhD, ATC, University of Michigan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Drug: Somatropin Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Recombinant Growth Hormone Therapy to Prevent Muscle Atrophy in Patients With Anterior Cruciate Ligament Tears
Actual Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones Tears

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Somatropin
Somatropin of rDNA origin
 Drug: 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.
Placebo Comparator: Placebo
A placebo vehicle that contains somatropin diluent but no active hormone.
 Drug: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in isokinetic and isometric strength measurements of thigh muscles from pre-operative levels [ Time Frame: 1 wk pre-op to 26 wk post-op ]

Secondary Outcome Measures :
  1. Changes in patient completed surveys [ Time Frame: 1 wk pre-op, 2 wk post-op, 5 wk post-op, 12 wk post-op, 18 wk post-op, 26 wk post-op ]
    International Knee Documentation Committee, Veterans Rand-12, Knee injury and Osteoarthritis Outcome Score, Lysholm Knee Score

  2. Changes in MRI assessment of muscle volume [ Time Frame: 1 wk pre-op, 5 wk post-op, 26 wk post-op ]
  3. Changes in blood work/diagnostic labs [ Time Frame: 1 wk pre-op, 2 wk post-op, 5 wk post-op, 12 wk post-op, 18 wk post-op, 26 wk post-op ]
    CBC, metabolic panel, CRP, HbA1C, COMP, myostatin, TGF-b, IGF-1, lipid panel

  4. Changes in isokinetic and isometric strength measurements of thigh muscles [ Time Frame: 1 wk pre-op, 2 wk post-op, 5 wk post-op, 12 wk post-op, 18 wk post-op, 26 wk post-op ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02420353


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Christopher L Mendias, PhD, ATC University of Michigan
More Information
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Publications:

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Responsible Party: Christopher Mendias, PhD, ATC, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02420353     History of Changes
Other Study ID Numbers: HUM00087702
IND Exemption 123189 ( Other Identifier: FDA )
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

Keywords provided by Christopher Mendias, PhD, ATC, University of Michigan:
muscle atrophy
growth hormone
ACL tear

Additional relevant MeSH terms:
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Atrophy
Rupture
Muscular Atrophy
Anterior Cruciate Ligament Injuries
Pathological Conditions, Anatomical
Wounds and Injuries
Neuromuscular Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Knee Injuries
Leg Injuries
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs