NCT01158612

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

July 7, 2010

Last Update Submit

November 4, 2011

Conditions

Growth HormoneElderly

Outcome Measures

Primary Outcomes (1)

  • • Fraktionele collagen protein synthesis in human patella tendon

    01122010

Study Arms (2)

Growth hormone

EXPERIMENTAL

The effect of Growth hormone on the collagen synthesis rate

Drug: Growth Hormone

Saline

PLACEBO COMPARATOR
Drug: Growth Hormone

Interventions

Growth HormoneDRUG

infusion of Growth hormone in the patella tendon.

Also known as: infusion of Saline in the patella tendon.
Growth hormoneSaline

Eligibility Criteria

Age55 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI 18.5 - 25.0

You may not qualify if:

  • earlier knee injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Århus universitetshospital nørrebrogade 44

Århus C, 8000, Denmark

Location

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Mette Hansen, PH.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 8, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2011

Study Completion

August 1, 2011

Last Updated

November 7, 2011

Record last verified: 2011-11

Locations

DK(1)