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

NCT01834989 | Unknown Early Phase 1

• 1 other identifier: H-4-2012-078
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Tendon structure

  After 12 weeks intervention (tendon biopsy)

Secondary Outcomes (1)

• Tendon Pain

  1 year (before and after 12 weeks intervention and 1 year after intervention start)

Study Arms (2)

Insulin-like growth factor I

ACTIVE COMPARATOR

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

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

Drug: Placebo

Interventions

Insulin-like growth factor I DRUG

Insulin-like growth factor I

Placebo DRUG

Also known as: Saline Injections

Placebo injections

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• The Danish Medical Research Council: collaborator

Study Sites (1)

Institute of Sports Medicine, Copenhagen

Copenhagen, 2400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 34138667 DERIVED

Related Links

• Study location

MeSH Terms

Conditions

Tendinopathy

Interventions

Insulin-Like Growth Factor I

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Somatomedins; Insulin-Like Peptides; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Blood Proteins; Proteins; Biological Factors

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor, PhD

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: December 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

DK (1)