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Teriparatide for Improved Knee Prosthesis Fixation

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ClinicalTrials.gov Identifier: NCT01063504
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: teriparatide Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : February 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Teriparatide 20 microgram daily for 2 months Drug: teriparatide
Placebo Comparator: Placebo Drug: teriparatide



Primary Outcome Measures :
  1. Migration as measured by RSA maximal total point motion. [ Time Frame: 2 years ]


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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee planned for prosthesis surgery

Exclusion Criteria:

  • Poor health, drugs affecting bone metabolism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063504


Locations
Sweden
Motala hospital
Motala, Sweden
Sponsors and Collaborators
University Hospital, Linkoeping

Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01063504     History of Changes
Other Study ID Numbers: PTHKnee
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs