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

NCT ID: NCT01158612

Last Updated: 2011-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Growth Hormone Elderly

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Growth hormone

The effect of Growth hormone on the collagen synthesis rate

Group Type EXPERIMENTAL

Growth Hormone

Intervention Type DRUG

infusion of Growth hormone in the patella tendon.

Saline

Group Type PLACEBO_COMPARATOR

Growth Hormone

Intervention Type DRUG

infusion of Growth hormone in the patella tendon.

Interventions

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Growth Hormone

infusion of Growth hormone in the patella tendon.

Intervention Type DRUG

Other Intervention Names

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infusion of Saline in the patella tendon.

Eligibility Criteria

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Inclusion Criteria

* BMI 18.5 - 25.0

Exclusion Criteria

* earlier knee injury
Minimum Eligible Age

55 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mette Hansen, PH.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Århus universitetshospital nørrebrogade 44

Århus C, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2010-039

Identifier Type: -

Identifier Source: org_study_id