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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Bispebjerg Hospital
The Danish Medical Research Council
Information provided by (Responsible Party):
Mette Hansen, Bispebjerg Hospital Identifier:
First received: April 16, 2013
Last updated: July 28, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Drug: Insulin-like growth factor I
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy

Resource links provided by NLM:

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Tendon structure [ Time Frame: After 12 weeks intervention (tendon biopsy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tendon Pain [ Time Frame: 1 year (before and after 12 weeks intervention and 1 year after intervention start) ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01834989

Contact: Mette Hansen, Ass. Professor +45 51666551
Contact: Michael Kjaer, Professor +45 35316089

Institute of Sports Medicine, Copenhagen Recruiting
Copenhagen, Denmark, 2400
Contact: Michael Kjaer, Professor    +4535316089   
Contact: Mette Hansen, Ass. Profes.    +45 51666551   
Principal Investigator: Mette Hansen, Ass. Profes.         
Principal Investigator: Michael Kjaer, Professor         
Principal Investigator: Jens Olesen, MD, PhD         
Sponsors and Collaborators
Bispebjerg Hospital
The Danish Medical Research Council
Principal Investigator: Michael Kjaer, Professor Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, Denmark
Principal Investigator: Mette Hansen, PhD Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, Denmark
Principal Investigator: Jens Olesen, PhD Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark
  More Information

Additional Information:
No publications provided

Responsible Party: Mette Hansen, Associated Professor, PhD, Bispebjerg Hospital Identifier: NCT01834989     History of Changes
Other Study ID Numbers: H-4-2012-078
Study First Received: April 16, 2013
Last Updated: July 28, 2015
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Complement Factor I
Complement Inactivating Agents
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 24, 2015