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A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy

Primary Purpose

Tendinopathy

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Somatropin
Bacteriostatic saline
Progressive exercise program
Patellar tendon biopsy
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tendinopathy focused on measuring patellar tendinopathy, somatropin, jumper's knee

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drug: Somatropin

Drug: Placebo

Arm Description

Under ultrasound guidance, patients will receive an injection of somatropin (0.1mg in a volume of 0.2mL of bacteriostatic saline) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.

Under ultrasound guidance, patients will receive an injection of 0.2mL of bacteriostatic saline (which is an equivalent volume of diluent used in the active comparator arm) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.

Outcomes

Primary Outcome Measures

Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment

Secondary Outcome Measures

Change in patient completed visual analog scale (VAS) of knee pain levels
Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score
Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test
Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Short Form Global Health Scale
Ultrasound assessment of patellar tendon quality
Five point assessment scale of tendon quality (0 Normal, Normal tendon structure; 1 Mild, Ill-defined abnormal hypoechogenicity; 2 Moderate, Well-defined abnormal hypoechogenicity; 3 Severe, Well-defined abnormal hypoechogenicity and anechoic clefts; 4 Complete, Full-width tendon disruption or tear)
Electron micrographs of patellar tendon biopsy sample
Bilateral biopsies will be taken, and the size (measured in squared nanometers) will be measured
Gene expression of patellar tendon biopsy sample
Bilateral biopsies will be taken, and the expression of genes will be measured with microarrays or RNA-sequencing

Full Information

First Posted
November 3, 2015
Last Updated
March 29, 2022
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02597660
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI decided not to enroll
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
patellar tendinopathy, somatropin, jumper's knee

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: Somatropin
Arm Type
Active Comparator
Arm Description
Under ultrasound guidance, patients will receive an injection of somatropin (0.1mg in a volume of 0.2mL of bacteriostatic saline) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
Arm Title
Drug: Placebo
Arm Type
Placebo Comparator
Arm Description
Under ultrasound guidance, patients will receive an injection of 0.2mL of bacteriostatic saline (which is an equivalent volume of diluent used in the active comparator arm) into the area of tendinopathic lesion. A series of three injections will be delivered one week apart. Vials will be blinded.
Intervention Type
Drug
Intervention Name(s)
Somatropin
Other Intervention Name(s)
Growth hormone, Human growth hormone
Intervention Description
Active drug
Intervention Type
Drug
Intervention Name(s)
Bacteriostatic saline
Other Intervention Name(s)
Saline, 0.9% NaCl
Intervention Description
Placebo, the diluent used to reconstitute somatropin
Intervention Type
Other
Intervention Name(s)
Progressive exercise program
Intervention Description
Over a 12 week period beginning at the second study visit patients will perform a standard of care eccentric exercise training regime. Each session consists of three bilateral exercises: leg press, back squat, and hack squat. Subjects will complete four sets in each exercise with a 2-3 minute rest between sets. The repetitions/loads are: 15 repetition maximum (RM) week 1, 12RM weeks 2-3, 10RM weeks 4-5, 8RM weeks 6-8 and 6RM weeks 9-12. All exercises are performed from complete 0º to 90º of knee flexion and back again. Each of the eccentric and concentric phases will occur over a period of 3 seconds, respectively for a total of 6 seconds per contraction.
Intervention Type
Procedure
Intervention Name(s)
Patellar tendon biopsy
Intervention Description
Bilateral biopsies will be performed on an elective basis, although the investigators will aim to have 8 subjects in each group receive the biopsy. Biopsies will be obtained at the 26 week time point. The data obtained from the biopsy will help address the mechanism behind observed changes in outcome scores, physical measurements or imaging studies. The biopsy will be performed under ultrasound guidance and using sterile technique with a disposable 14G, 2cm biopsy instrument.
Primary Outcome Measure Information:
Title
Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment
Time Frame
Week 1 to week 26
Secondary Outcome Measure Information:
Title
Change in patient completed visual analog scale (VAS) of knee pain levels
Time Frame
Week 1, 2, 3, 4, 9, 14, 26
Title
Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score
Time Frame
Week 1, 2, 3, 4, 9, 14, 26
Title
Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test
Time Frame
Week 1, 2, 3, 4, 9, 14, 26
Title
Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Short Form Global Health Scale
Time Frame
Week 1, 2, 3, 4, 9, 14, 26
Title
Ultrasound assessment of patellar tendon quality
Description
Five point assessment scale of tendon quality (0 Normal, Normal tendon structure; 1 Mild, Ill-defined abnormal hypoechogenicity; 2 Moderate, Well-defined abnormal hypoechogenicity; 3 Severe, Well-defined abnormal hypoechogenicity and anechoic clefts; 4 Complete, Full-width tendon disruption or tear)
Time Frame
Weeks 1, 14, 26
Title
Electron micrographs of patellar tendon biopsy sample
Description
Bilateral biopsies will be taken, and the size (measured in squared nanometers) will be measured
Time Frame
Week 26
Title
Gene expression of patellar tendon biopsy sample
Description
Bilateral biopsies will be taken, and the expression of genes will be measured with microarrays or RNA-sequencing
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher L Mendias, PhD, ATC
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24235105
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.
Results Reference
background
PubMed Identifier
24081158
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.
Results Reference
background
PubMed Identifier
25607281
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.
Results Reference
background
PubMed Identifier
22429205
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.
Results Reference
background
PubMed Identifier
19793213
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.
Results Reference
background
PubMed Identifier
9732118
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.
Results Reference
background
PubMed Identifier
24378399
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.
Results Reference
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A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy

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