Teriparatide for Improved Knee Prosthesis Fixation

• Sponsor: University Hospital, Linkoeping (Other)
• Overall Status: Completed
• CT.gov ID: NCT01063504
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 1.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis of the Knee	Drug: teriparatide	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Migration as measured by RSA maximal total point motion. [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Osteoarthritis of the knee planned for prosthesis surgery

Exclusion Criteria:

• Poor health, drugs affecting bone metabolism.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Motala hospital	Motala		Sweden

Sponsors and Collaborators

• University Hospital, Linkoeping

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Per Aspenberg, professor, University Hospital, Linkoeping
• ClinicalTrials.gov Identifier: NCT01063504
• Other Study ID Numbers: PTHKnee
• First Posted: Feb 5, 2010
• Last Update Posted: Jun 19, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Osteoarthritis, Knee; Teriparatide

Study Results

No Results Posted as of Jun 19, 2013