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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01834989
First Posted: April 18, 2013
Last Update Posted: February 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Danish Medical Research Council
Information provided by (Responsible Party):
Mette Hansen, Bispebjerg Hospital
  Purpose
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
Tendinopathy Drug: Insulin-like growth factor I Drug: Placebo Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Mette Hansen, Bispebjerg Hospital:

Primary Outcome Measures:
  • Tendon structure [ Time Frame: After 12 weeks intervention (tendon biopsy) ]

Secondary Outcome Measures:
  • Tendon Pain [ Time Frame: 1 year (before and after 12 weeks intervention and 1 year after intervention start) ]
    questionnaire


Enrollment: 40
Actual Study Start Date: April 2013
Estimated Study Completion Date: June 2018
Primary Completion Date: February 1, 2017 (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
Drug: Placebo
Other Name: Saline Injections

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
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834989


Locations
Denmark
Institute of Sports Medicine, Copenhagen
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
The Danish Medical Research Council
Investigators
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:
Responsible Party: Mette Hansen, Associated Professor, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01834989     History of Changes
Other Study ID Numbers: H-4-2012-078
First Submitted: April 16, 2013
First Posted: April 18, 2013
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Insulin, Globin Zinc
Insulin
Mitogens
Complement Factor I
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors