TendinopathyEarly Phase 1IGF-INCT01834989
Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I
A Early Phase 1 study testing Insulin-like growth factor I in people with Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Insulin-like growth factor I
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to 1 Dec 2020
- Phase
- Early Phase 1
- 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
- chronic patellar tendinopathy (> 3 months)
- anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
- hypo-echoic area with enhanced vascularization
Who cannot join
- corticosteroid injection within the last 12 months
- Knee operation
- Knee osteoarthritis
- Diabetes
- Smoking
- Body mass index >30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy
The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.
Read the detailed description
Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up
- Conditions
- Tendinopathy
- Being tested
- Insulin-like growth factor I, Placebo
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin-like growth factor IDrug
PlaceboDrug
Also called Saline Injections
| Study group | Role | What they receive |
|---|---|---|
| Insulin-like growth factor I | Active comparator | 3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention Receives: Drug: Insulin-like growth factor I |
| Placebo injections | Placebo comparator | 3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tendon structure
Measured: After 12 weeks intervention (tendon biopsy)
Secondary outcomes (1)
Tendon Pain
questionnaire
Measured: 1 year (before and after 12 weeks intervention and 1 year after intervention start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion1 Feb 2017
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Responsible party
- Principal investigator, Mette Hansen, Bispebjerg Hospital
- Investigators
- Michael Kjaer, Professor, Principal investigator, Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, DenmarkMette Hansen, PhD, Principal investigator, Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, DenmarkJens Olesen, PhD, Principal investigator, Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834989
- Sponsor's protocol ID
- H-4-2012-078
- Acronym
- IGF-I
- Status last verified
- Jul 2020
- First submitted
- 16 Apr 2013
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Olesen JL, Hansen M, Turtumoygard IF, Hoffner R, Schjerling P, Christensen J, Mendias CL, Magnusson PS, Kjaer M. No Treatment Benefits of Local Administration of Insulin-like Growth Factor-1 in Addition to Heavy Slow Resistance Training in Tendinopathic Human Patellar Tendons: A Randomized, Double-Blind, Placebo-Controlled Trial With 1-Year Follow-up. Am J Sports Med. 2021 Jul;49(9):2361-2370. doi: 10.1177/03635465211021056. Epub 2021 Jun 17.
PubMed 34138667
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy
- ClinicalTrials.gov ID
- NCT01834989
- Acronym / sponsor ID
- IGF-I / H-4-2012-078
- Conditions
- Tendinopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Apr 2013 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 18 Apr 2013 (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.
The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.
Detailed description
Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin-like growth factor I | Active comparator | Drug: Insulin-like growth factor I3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention |
| Placebo injections | Placebo comparator | Drug: Placebo3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- chronic patellar tendinopathy (> 3 months)
- anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
- hypo-echoic area with enhanced vascularization
Key exclusion criteria (6 listed)
- corticosteroid injection within the last 12 months
- Knee operation
- Knee osteoarthritis
- Diabetes
- Smoking
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 |
|---|---|---|
| Insulin-like growth factor I | Drug | Insulin-like growth factor I |
| PlaceboAlso: Saline Injections | Drug | Placebo injections |
Primary outcome
Tendon structure
Time frame: After 12 weeks intervention (tendon biopsy)
1 secondary outcome
Tendon Pain
Time frame: 1 year (before and after 12 weeks intervention and 1 year after intervention start)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 34138667Olesen JL, Hansen M, Turtumoygard IF, Hoffner R, Schjerling P, Christensen J, Mendias CL, Magnusson PS, Kjaer M. No Treatment Benefits of Local Administration of Insulin-like Growth Factor-1 in Addition to Heavy Slow Resistance Training in Tendinopathic Human Patellar Tendons: A Randomized, Double-Blind, Placebo-Controlled Trial With 1-Year Follow-up. Am J Sports Med. 2021 Jul;49(9):2361-2370. doi: 10.1177/03635465211021056. Epub 2021 Jun 17.
- Study locationLink provided by the sponsor.
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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.
Michael Kjaer, Professor principal investigator
Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, Denmark
Mette Hansen, PhD principal investigator
Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, Denmark
Jens Olesen, PhD principal investigator
Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Insulin-like growth factor I in people with Tendinopathy, run by Bispebjerg Hospital at 1 site in Denmark.
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 6 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. 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 Denmark. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Tendon structure (time frame: After 12 weeks intervention (tendon biopsy)). 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 NCT01834989, which also lists 1 linked publication.
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 29 Jul 2020.