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Status unknownNCT01834989IGF-IUpdated Jul 29, 2020

Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I

An Early Phase 1 interventional study of Insulin-like growth factor I and Placebo in Tendinopathy, sponsored by Bispebjerg Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-07-29.

Sponsored by Bispebjerg Hospital · Early Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Tendinopathy

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03

In context

Tendinopathy

413 studies on the registry are indexed under Tendinopathy; 64 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 339 interventional studies indexed under Tendinopathy.

Browse Tendinopathy studies →

Lead sponsor

Bispebjerg Hospital is the lead sponsor of 281 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • chronic patellar tendinopathy (> 3 months)
  • anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
  • hypo-echoic area with enhanced vascularization

Exclusion Criteria: injection

  • corticosteroid injection within the last 12 months
  • Knee operation
  • Knee osteoarthritis
  • Diabetes
  • Smoking
  • Body mass index >30
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Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Insulin-like growth factor I

    3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention

    Drug: Insulin-like growth factor I

  • Placebo comparator
    Placebo injections

    3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period

    Drug: Placebo

Interventions

  • DrugInsulin-like growth factor I
  • DrugPlacebo

    Also known as: Saline Injections

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What researchers measure

Primary outcomes

  1. Tendon structure

    Time frame: After 12 weeks intervention (tendon biopsy)

Secondary outcomes

  1. Tendon Pain

    questionnaire

    Time frame: 1 year (before and after 12 weeks intervention and 1 year after intervention start)

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Study locations

1 site
  • Institute of Sports Medicine, Copenhagen
    Copenhagen, 2400, Denmark
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References and documents

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 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01834989
Lead sponsor
Bispebjerg Hospital
Collaborators
The Danish Medical Research Council
Responsible party
Mette Hansen (Associated Professor, PhD, Bispebjerg Hospital) — Principal investigator
First posted
Apr 18, 2013
Start date
Apr 2013
Primary completion
Feb 1, 2017
Completion
Dec 1, 2020 (estimated)
Last update
Jul 29, 2020

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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