Clinical trial NCT02597660: A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
Official title: A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Tendinopathy
Keywords: patellar tendinopathy
somatropin
jumper's knee
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patellar tendinopathy is one of the most frequent causes of non-traumatic knee pain and reduced function in patients. Standard treatment options for patellar tendinopathies include non-steroidal anti-inflammatory drugs, corticosteroids, cryotherapy, manual therapy, eccentric exercises, and ultrasound. Unfortunately many patients fail to respond to these therapies and return to normal activity levels, and recurrence rates for those who do respond are unacceptably high. Many patients who fail to respond display persistent degenerative changes on imaging studies suggesting a failure to regenerate the pathological tissue. Developing new therapies that can directly promote the synthesis of new, healthy extracellular matrix tissue could therefore address an important therapeutic need and make a substantial improvement in our ability to effectively treat patellar tendinopathy and reduce recurrence rates. Somatropin (human growth hormone of recombinant DNA origin) has been shown to increase protein synthesis and matrix production when delivered directly into the tendon. This study will evaluate the ability of somatropin to improve clinical outcomes and tissue quality in patients with chronic tendinopathy.


Eligibility criteria: Inclusion Criteria:

* Males and females ages 18 - 50
* Patients with a greater than 3 month history of anterior knee pain
* Patients with a confirmed diagnosis of patellar tendinopathy (confirmation by ultrasonography demonstrating local anterior-posterior thickening of the tendon of at least 1mm compared with the mid-tendon level, and a hypo-echoic area)

Exclusion Criteria:

* Patients who have received corticosteroid injections within 12 months
* Patients who have full-width disruptions of the patellar tendon
* Patients who have undergone previous knee surgery or intraarticular injury
* Patients who have have arthritis (Kellgren and Lawrence grade 2 or higher), open growth plates, diabetes, cardiovascular disease, history of cancer or any major medical illnesses or endocrine disorders
* Patients with a body mass index greater than 35
* Women who are pregnant or planning to become pregnant
* Patients who are current collegiate, professional or elite athletes, or are participating in sports organizations that currently ban the use of somatropin

Primary outcomes:
measure: Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment
timeFrame: Week 1 to week 26
Secondary outcomes:
measure: Change in patient completed visual analog scale (VAS) of knee pain levels
timeFrame: Week 1, 2, 3, 4, 9, 14, 26
measure: Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score
timeFrame: Week 1, 2, 3, 4, 9, 14, 26
measure: Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test
timeFrame: Week 1, 2, 3, 4, 9, 14, 26
measure: Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Short Form Global Health Scale
timeFrame: Week 1, 2, 3, 4, 9, 14, 26
measure: Ultrasound assessment of patellar tendon quality
timeFrame: Weeks 1, 14, 26
measure: Electron micrographs of patellar tendon biopsy sample
timeFrame: Week 26
measure: Gene expression of patellar tendon biopsy sample
timeFrame: Week 26
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Christopher L Mendias, PhD, ATC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boesen AP, Dideriksen K, Couppe C, Magnusson SP, Schjerling P, Boesen M, Aagaard P, Kjaer M, Langberg H. Effect of growth hormone on aging connective tissue in muscle and tendon: gene expression, morphology, and function following immobilization and rehabilitation. J Appl Physiol (1985). 2014 Jan 15;116(2):192-203. doi: 10.1152/japplphysiol.01077.2013. Epub 2013 Nov 14.
citation: Boesen AP, Dideriksen K, Couppe C, Magnusson SP, Schjerling P, Boesen M, Kjaer M, Langberg H. Tendon and skeletal muscle matrix gene expression and functional responses to immobilisation and rehabilitation in young males: effect of growth hormone administration. J Physiol. 2013 Dec 1;591(23):6039-52. doi: 10.1113/jphysiol.2013.261263. Epub 2013 Sep 30.
citation: Gumucio JP, Sugg KB, Mendias CL. TGF-beta superfamily signaling in muscle and tendon adaptation to resistance exercise. Exerc Sport Sci Rev. 2015 Apr;43(2):93-9. doi: 10.1249/JES.0000000000000041.
citation: Heinemeier KM, Mackey AL, Doessing S, Hansen M, Bayer ML, Nielsen RH, Herchenhan A, Malmgaard-Clausen NM, Kjaer M. GH/IGF-I axis and matrix adaptation of the musculotendinous tissue to exercise in humans. Scand J Med Sci Sports. 2012 Aug;22(4):e1-7. doi: 10.1111/j.1600-0838.2012.01459.x. Epub 2012 Mar 19.
citation: Kongsgaard M, Kovanen V, Aagaard P, Doessing S, Hansen P, Laursen AH, Kaldau NC, Kjaer M, Magnusson SP. Corticosteroid injections, eccentric decline squat training and heavy slow resistance training in patellar tendinopathy. Scand J Med Sci Sports. 2009 Dec;19(6):790-802. doi: 10.1111/j.1600-0838.2009.00949.x. Epub 2009 May 28.
citation: Visentini PJ, Khan KM, Cook JL, Kiss ZS, Harcourt PR, Wark JD. The VISA score: an index of severity of symptoms in patients with jumper's knee (patellar tendinosis). Victorian Institute of Sport Tendon Study Group. J Sci Med Sport. 1998 Jan;1(1):22-8. doi: 10.1016/s1440-2440(98)80005-4.
citation: Hung M, Stuart AR, Higgins TF, Saltzman CL, Kubiak EN. Computerized Adaptive Testing Using the PROMIS Physical Function Item Bank Reduces Test Burden With Less Ceiling Effects Compared With the Short Musculoskeletal Function Assessment in Orthopaedic Trauma Patients. J Orthop Trauma. 2014 Aug;28(8):439-43. doi: 10.1097/BOT.0000000000000059.