NCT02420353

Evaluation of Recombinant Growth Hormone Therapy to Prevent Muscle Atrophy in Patients With Anterior Cruciate Ligament Tears

Completed Phase 2 Results posted Last updated 17 December 2019

What this trial tests

Phase 2 trial testing Somatropin in Rupture of Anterior Cruciate Ligament in 20 participants. Completed in 1 October 2018.

Timeline

1 May 2015

Primary endpoint
1 October 2018

1 October 2018

Quick facts

Lead sponsor	University of Michigan
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	20
Start date	1 May 2015
Primary completion	1 October 2018
Estimated completion	1 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Somatropin (Somatropin) — full drug profile →
• Placebo

Conditions studied

• Rupture of Anterior Cruciate Ligament — all drugs for Rupture of Anterior Cruciate Ligament →

Sponsor

University of Michigan

Who can join

Adults 18 to 35, male only, with Rupture of Anterior Cruciate Ligament. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Normative Isokinetic Knee Extension Strength, Measured in Newton Meters (Nm) at 26 Weeks Post-op
  Time frame: at 26 wks post-op
  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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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 CL, Enselman ERS, Olszewski AM, Gumucio JP, et al · · 2020 · cited 15× · PMID 32452208 · DOI 10.1177/0363546520920591