- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063504
Teriparatide for Improved Knee Prosthesis Fixation
June 17, 2013 updated by: Per Aspenberg, University Hospital, Linkoeping
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).
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Motala, Sweden
- Motala Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Osteoarthritis of the knee planned for prosthesis surgery
Exclusion Criteria:
- Poor health, drugs affecting bone metabolism.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Active Comparator: Teriparatide 20 microgram daily for 2 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Migration as measured by RSA maximal total point motion.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
February 4, 2010
First Submitted That Met QC Criteria
February 4, 2010
First Posted (Estimate)
February 5, 2010
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTHKnee
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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