Teriparatide for Improved Knee Prosthesis Fixation

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Per Aspenberg, University Hospital, Linkoeping

ClinicalTrials.gov Identifier:

NCT01063504

First received: February 4, 2010

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 4, 2010
Last Updated Date	June 14, 2012
Start Date ^ICMJE	February 2010
Estimated Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 4, 2010)	Migration as measured by RSA maximal total point motion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01063504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Teriparatide for Improved Knee Prosthesis Fixation
Official Title ^ICMJE	Not Provided
Brief Summary	The investigators will study how well knee joint prostheses become fixed to the bone when patients get teriparatide, compared to placebo. Measurements will use high resolution 3D radiography (radiostereometry, RSA).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Osteoarthritis of the Knee
Intervention ^ICMJE	Drug: teriparatide
Study Arm (s)	Active Comparator: Teriparatide 20 microgram daily for 2 months Intervention: Drug: teriparatide Placebo Comparator: Placebo Intervention: Drug: teriparatide
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	60
Estimated Completion Date	February 2013
Estimated Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Osteoarthritis of the knee planned for prosthesis surgery Exclusion Criteria: Poor health, drugs affecting bone metabolism.
Gender	Both
Ages	60 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT01063504
Other Study ID Numbers ^ICMJE	PTHKnee
Has Data Monitoring Committee	Yes
Responsible Party	Per Aspenberg, University Hospital, Linkoeping
Study Sponsor ^ICMJE	University Hospital, Linkoeping
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Linkoeping
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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