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The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella

This study has been completed.
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01158612
First received: July 7, 2010
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.


Condition Intervention
Growth Hormone
Elderly
 Drug: Growth Hormone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effect of Local Injectet GH on the Collagen Synthesis in the Ligamentum Patella

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • • Fraktionele collagen protein synthesis in human patella tendon [ Time Frame: 01122010 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Growth hormone
The effect of Growth hormone on the collagen synthesis rate
 Drug: Growth Hormone
infusion of Growth hormone in the patella tendon.
Other Name: infusion of Saline in the patella tendon.
Placebo Comparator: Saline Drug: Growth Hormone
infusion of Growth hormone in the patella tendon.
Other Name: infusion of Saline in the patella tendon.

Detailed Description:

Tendon and ligament injuries are a frequent problem among athletes but also in the general population. The healing process is a prolonged process, and complete recovery of tissue strength is nearly never reached. The purpose of this study is to examine the effect of local injection of human Growth Hormone on tendon collagen synthesis.

in order to investigate the collagen synthesis potential and the influence of growth hormone, 12 elderly males age > 50 year, is enrolled in this study.

  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI 18.5 - 25.0

Exclusion Criteria:

  • earlier knee injury
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158612

Locations
Denmark
Århus universitetshospital nørrebrogade 44
Århus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Bispebjerg Hospital
Investigators
Principal Investigator: Mette Hansen, PH.D.
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01158612     History of Changes
Other Study ID Numbers: H-2-2010-039
Study First Received: July 7, 2010
Last Updated: November 4, 2011
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013