Back to resultsTeriparatide for Improved Knee Prosthesis Fixation
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
teriparatide
Sponsored by
About this trial
This is an interventional prevention trial for Osteoarthritis of the Knee
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis of the knee planned for prosthesis surgery
Exclusion Criteria:
- Poor health, drugs affecting bone metabolism.
Sites / Locations
- Motala hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Teriparatide 20 microgram daily for 2 months
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Migration as measured by RSA maximal total point motion.
Secondary Outcome Measures
Full Information
NCT ID
NCT01063504
First Posted
February 4, 2010
Last Updated
June 17, 2013
Sponsor
University Hospital, Linkoeping
1. Study Identification
Unique Protocol Identification Number
NCT01063504
Brief Title
Teriparatide for Improved Knee Prosthesis Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Teriparatide 20 microgram daily for 2 months
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
teriparatide
Primary Outcome Measure Information:
Title
Migration as measured by RSA maximal total point motion.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Osteoarthritis of the knee planned for prosthesis surgery
Exclusion Criteria:
Poor health, drugs affecting bone metabolism.
Facility Information:
Facility Name
Motala hospital
City
Motala
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Teriparatide for Improved Knee Prosthesis Fixation
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