Teriparatide for Improved Knee Prosthesis Fixation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Per Aspenberg, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01063504
First received: February 4, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Osteoarthritis of the Knee
Drug: teriparatide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Migration as measured by RSA maximal total point motion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Teriparatide 20 microgram daily for 2 months Drug: teriparatide
Placebo Comparator: Placebo Drug: teriparatide

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis of the knee planned for prosthesis surgery

Exclusion Criteria:

  • Poor health, drugs affecting bone metabolism.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063504

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

No publications provided

Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01063504     History of Changes
Other Study ID Numbers: PTHKnee
Study First Received: February 4, 2010
Last Updated: June 17, 2013
Health Authority: Sweden: Ministry of education and research

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

ClinicalTrials.gov processed this record on July 20, 2014