Does teriparatide lower the risk for loosening of a knee prosthesis?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011784-37-SE

Enrollment

Registered

2009-08-20

Start date

2009-09-17

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritis. In animal studies teriparatide has shown a positive effect on fracture healing. So far, teriparatide (Forsteo ®) is only registrered for treatment of severe osteoporosis. A cemented total knee replacement needs "a healing process" between bone and cement to aquire stability. Studies using roentgen stereometric analysis (RSA) have shown that minimal but early migration of a prosthesis precludes later loosening.

Interventions

Trade Name: Forsteo Pharmaceutical Form: Injection* INN or Proposed INN: TERIPARATIDE CAS Number: 52232-67-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients suitable for elective total knee replacement due to primary or secondary osteoarthritis. 2. Ability to give informed consent 3. ASA group 1-2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Rheumatic disease • Anamnes på svårare hjärtsjukdom , se ASA 1-4 enligt ovan • Reduced renal function - plasma creatinine >150 mmol/L for males, >125 for females • Simultaneous bilateral surgery • History of allergic reaction to the drug • Hypercalcemia • Metabolic diseases affecting the bone i.e. Pagets disease • Malignancy • Previous radiation

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate if teriparatide given postoperatively to patients undergoing total knee replacement will lower the risk for late loosening of the prosthesis;Secondary Objective: No;Primary end point(s): The migration of the tibial part of the prosthesis will be analyzed during the first 2 years postoperatively using RSA (measures used will be translation, rotation och MTPM (maximal total point motion)). The patients will be randomized to either active treatment with teriparatide or no treatment	—

Measure

Time frame

Main Objective: To evaluate if teriparatide given postoperatively to patients undergoing total knee replacement will lower the risk for late loosening of the prosthesis;Secondary Objective: No;Primary end point(s): The migration of the tibial part of the prosthesis will be analyzed during the first 2 years postoperatively using RSA (measures used will be translation, rotation och MTPM (maximal total point motion)). The patients will be randomized to either active treatment with teriparatide or no treatment

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026