The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

Bone Resorption Clinical Trial

Official title:

The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty: A Randomised, Double Blind, Placebo Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02760979
• Other study ID #: IIBSP-DEN-2012-24
• Secondary ID: 2012-001285-15
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2016
• Last updated: August 10, 2017
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: August 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.

Description:

Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery.

2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty

Exclusion Criteria:

• Patients allergies to Denosumab

• Patients with previous Osteoporosis treatment

• Patients with renal failure

• Patients with previous Bisphosphonate treatment for more than 5 years

Related Conditions & MeSH terms

• Bone Resorption

Intervention

Drug:
• Denosumab
Denosumab treatment one year after surgery
• Placebo
Serum one year after surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

References & Publications (3)

Ishii Y, Yagisawa K, Ikezawa Y. Changes in bone mineral density of the proximal femur after total knee arthroplasty. J Arthroplasty. 2000 Jun;15(4):519-22. — View Citation

Sugita T, Umehara J, Sato K, Inoue H. Influence of tibial bone quality on loosening of the tibial component in total knee arthroplasty for rheumatoid arthritis: long-term results. Orthopedics. 1999 Feb;22(2):213-5. — View Citation

Wang CJ, Wang JW, Weng LH, Hsu CC, Huang CC, Chen HS. The effect of alendronate on bone mineral density in the distal part of the femur and proximal part of the tibia after total knee arthroplasty. J Bone Joint Surg Am. 2003 Nov;85-A(11):2121-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bone Mass index	Bone Mass index in gr/cm3	Change in densitometry before surgery (0) and at three (3) months after surgery
Primary	Change in Bone Mass index	Bone Mass index in gr/cm3	Change in densitometry before surgery (0) and at six (6) months after surgery
Primary	Change in Bone Mass index	Bone Mass index in gr/cm3	Change in densitometry before surgery (0) and at twelve (12) months after surgery
Secondary	Quality of Life (WOMAC)		WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
Secondary	Quality of life (SF-36)		SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
Secondary	Kidney function	Creatinine clearance	Before surgery and at three, six and twelve months after surgery
Secondary	Liver function	ALT, AST	Before surgery and at three, six and twelve months after surgery
Secondary	Bone turnover markers	Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)	At three, six and twelve months after surgery