Clinical trial NCT02760979: The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Resorption
Keywords: knee arthroplasty
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Bone Mass index
timeFrame: Change in densitometry before surgery (0) and at three (3) months after surgery
measure: Change in Bone Mass index
timeFrame: Change in densitometry before surgery (0) and at six (6) months after surgery
measure: Change in Bone Mass index
timeFrame: Change in densitometry before surgery (0) and at twelve (12) months after surgery
Secondary outcomes:
measure: Quality of Life (WOMAC)
timeFrame: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
measure: Quality of life (SF-36)
timeFrame: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
measure: Kidney function
timeFrame: Before surgery and at three, six and twelve months after surgery
measure: Liver function
timeFrame: Before surgery and at three, six and twelve months after surgery
measure: Bone turnover markers
timeFrame: At three, six and twelve months after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
name: Jose Carlos Gonzalez
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1054/arth.2000.4639.
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. doi: 10.3928/0147-7447-19990201-10.
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(11):2121-6. doi: 10.2106/00004623-200311000-00009.