Skip to content

Trial · Interventional

WithdrawnPhase 2Registry data

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

NCTNCT02597660 (opens ClinicalTrials.gov in a new tab)Other idHUM00107019
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
Hospital for Special Surgery, New York · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
1 May 2020
Primary completion
1 Dec 2020
Completion
1 Dec 2020
First posted
5 Nov 2015 (estimated)
Last update posted
31 Mar 2022
Conditions
Tendinopathy

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20202021
  1. Ph 2

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

    NCT02597660

    1 May 2020 to 1 Dec 2020

    Withdrawn

Registry summary

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

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.

Interventions

  • SomatropinDrug
  • Bacteriostatic salineDrug
  • Progressive exercise programOther
  • Patellar tendon biopsyProcedure

Arms2

  • Active comparator

    Drug: Somatropin

    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.

  • Placebo comparator

    Drug: Placebo

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Week 1 to week 26

Secondary outcomes(7)

  1. Change in patient completed visual analog scale (VAS) of knee pain levels

    Time frame · Week 1, 2, 3, 4, 9, 14, 26

  2. Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score

    Time frame · Week 1, 2, 3, 4, 9, 14, 26

  3. 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

  4. 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

  5. Ultrasound assessment of patellar tendon quality

    Time frame · Weeks 1, 14, 26

    Registry 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)

  6. Electron micrographs of patellar tendon biopsy sample

    Time frame · Week 26

    Registry description

    Bilateral biopsies will be taken, and the size (measured in squared nanometers) will be measured

  7. Gene expression of patellar tendon biopsy sample

    Time frame · Week 26

    Registry description

    Bilateral biopsies will be taken, and the expression of genes will be measured with microarrays or RNA-sequencing

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

3 results

Effect of growth hormone on aging connective tissue in muscle and tendon: gene expression, morphology, and function following immobilization and rehabilitation.

Boesen et al. 2014Journal of applied physiology (Bethesda, Md. : 1985)cited by 31

PMID 24235105DOI 10.1152/japplphysiol.01077.2013PUB-24235105

Full text at the publisher3 results
Publisher pageSee results (3)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLopes AD, Rizzo RR, Hespanhol L, Costa LO, Kamper SJ. Exercise for patellar tendinopathy. Cochrane Database Syst Rev. 2025 May 27;5(5):CD013078. doi: 10.1002/14651858.CD013078.pub2. PMID 40421598

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.