The Effect of Local Injectet GH on the Collagen Synthesis... | NCT01158612

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

NCT01158612

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Nov 7, 2011Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Growth Hormone
Elderly

Interventions

Growth Hormone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jul 7, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2011

Last Update Posted Date

Nov 7, 2011Estimated

Name	Class
Bispebjerg Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Growth hormone	Experimental	The effect of Growth hormone on the collagen synthesis rate	Drug: Growth Hormone
Saline	Placebo Comparator		Drug: Growth Hormone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Growth Hormone	Drug	infusion of Growth hormone in the patella tendon.	Growth hormone Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
• Fraktionele collagen protein synthesis in human patella tendon		01122010

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI 18.5 - 25.0

Exclusion Criteria:

earlier knee injury

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette Hansen, PH.D.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Århus universitetshospital nørrebrogade 44		Århus C		8000	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D013006	Growth Hormone

Ancestor Terms

ID	Term
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided