TendinopathyPhase 2NCT02597660
A Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
A Phase 2 study testing Somatropin, Bacteriostatic saline and Progressive exercise program in people with Tendinopathy, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Somatropin, Bacteriostatic saline and Progressive exercise program
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 1 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
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.
- Conditions
- Tendinopathy
- Being tested
- Somatropin, Bacteriostatic saline, Progressive exercise program, Patellar tendon biopsy
- Keywords
- patellar tendinopathy, somatropin, jumper's knee
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
Also called Growth hormone, Human growth hormone
Active drug
Bacteriostatic salineDrug
Also called Saline, 0.9% NaCl
Placebo, the diluent used to reconstitute somatropin
Progressive exercise programOther
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.
Patellar tendon biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Drug: Somatropin | Active comparator | 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. Receives: Drug: Somatropin; Other: Progressive exercise program; Procedure: Patellar tendon biopsy |
| Drug: Placebo | Placebo comparator | 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. Receives: Drug: Bacteriostatic saline; Other: Progressive exercise program; Procedure: Patellar tendon biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment
Measured: Week 1 to week 26
Secondary outcomes (7)
Change in patient completed visual analog scale (VAS) of knee pain levels
Measured: Week 1, 2, 3, 4, 9, 14, 26
Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score
Measured: Week 1, 2, 3, 4, 9, 14, 26
Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Physical Function Computer Adaptive Test
Measured: Week 1, 2, 3, 4, 9, 14, 26
Change in patient completed Patient Reported Outcomes Measurement Instrument System (PROMIS) Short Form Global Health Scale
Measured: Week 1, 2, 3, 4, 9, 14, 26
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)
Measured: Weeks 1, 14, 26
Electron micrographs of patellar tendon biopsy sample
Bilateral biopsies will be taken, and the size (measured in squared nanometers) will be measured
Measured: Week 26
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
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start1 May 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: PI decided not to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher L Mendias, PhD, ATC, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597660
- Sponsor's protocol ID
- HUM00107019
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 24235105Boesen 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.
PubMed 24081158Gumucio 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.
PubMed 25607281Heinemeier 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.
PubMed 22429205Kongsgaard 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.
PubMed 19793213Visentini 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.
PubMed 9732118Hung 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.
PubMed 24378399Lopes 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.
PubMed 40421598
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Somatropin in the Treatment of Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT02597660
- Acronym / sponsor ID
- HUM00107019
- Conditions
- Tendinopathy
- Keywords
- patellar tendinopathy, somatropin, jumper's knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decided not to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Somatropin | Active comparator | Drug: Somatropin, Other: Progressive exercise program, Procedure: Patellar tendon biopsyUnder 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. |
| Drug: Placebo | Placebo comparator | Drug: Bacteriostatic saline, Other: Progressive exercise program, Procedure: Patellar tendon biopsyUnder 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatropinAlso: Growth hormone, Human growth hormoneActive drug | Drug | Drug: Somatropin |
| Bacteriostatic salineAlso: Saline, 0.9% NaClPlacebo, the diluent used to reconstitute somatropin | Drug | Drug: Placebo |
| Progressive exercise programOver 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. | Other | Drug: Placebo, Drug: Somatropin |
| Patellar tendon biopsyBilateral 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. | Procedure or surgery | Drug: Placebo, Drug: Somatropin |
Primary outcome
Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment
Time frame: Week 1 to week 26
7 secondary outcomes
Change in patient completed visual analog scale (VAS) of knee pain levels
Time frame: Week 1, 2, 3, 4, 9, 14, 26
Change in patient completed Victorian Institute of Sport Assessment Patellar outcome score
Time frame: Week 1, 2, 3, 4, 9, 14, 26
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
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
Ultrasound assessment of patellar tendon quality
Time frame: Weeks 1, 14, 26
Electron micrographs of patellar tendon biopsy sample
Time frame: Week 26
Gene expression of patellar tendon biopsy sample
Time frame: Week 26
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 24235105Boesen 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.
- Background: PubMed 24081158Boesen 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.
- Background: PubMed 25607281Gumucio 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.
- Background: PubMed 22429205Heinemeier 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.
- Background: PubMed 19793213Kongsgaard 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.
- Background: PubMed 9732118Visentini 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.
- Background: PubMed 24378399Hung 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.
- Derived from this study: PubMed 40421598Lopes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher L Mendias, PhD, ATC principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin, Bacteriostatic saline and Progressive exercise program in people with Tendinopathy, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Victorian Institute of Sport Assessment Patellar outcome score from enrollment (time frame: Week 1 to week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597660, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.