The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
Primary Purpose
Bone Resorption
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Denosumab
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Bone Resorption focused on measuring knee arthroplasty
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Denosumab
Placebo
Arm Description
Patients treated with Denosumab
Patients treated with placebo
Outcomes
Primary Outcome Measures
Change in Bone Mass index
Bone Mass index in gr/cm3
Change in Bone Mass index
Bone Mass index in gr/cm3
Change in Bone Mass index
Bone Mass index in gr/cm3
Secondary Outcome Measures
Quality of Life (WOMAC)
Quality of life (SF-36)
Kidney function
Creatinine clearance
Liver function
ALT, AST
Bone turnover markers
Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
Full Information
NCT ID
NCT02760979
First Posted
April 28, 2016
Last Updated
August 10, 2017
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT02760979
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Resorption
Keywords
knee arthroplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Denosumab
Arm Type
Active Comparator
Arm Description
Patients treated with Denosumab
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with placebo
Intervention Type
Drug
Intervention Name(s)
Denosumab
Other Intervention Name(s)
Prolia
Intervention Description
Denosumab treatment one year after surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Serum
Intervention Description
Serum one year after surgery
Primary Outcome Measure Information:
Title
Change in Bone Mass index
Description
Bone Mass index in gr/cm3
Time Frame
Change in densitometry before surgery (0) and at three (3) months after surgery
Title
Change in Bone Mass index
Description
Bone Mass index in gr/cm3
Time Frame
Change in densitometry before surgery (0) and at six (6) months after surgery
Title
Change in Bone Mass index
Description
Bone Mass index in gr/cm3
Time Frame
Change in densitometry before surgery (0) and at twelve (12) months after surgery
Secondary Outcome Measure Information:
Title
Quality of Life (WOMAC)
Time Frame
WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
Title
Quality of life (SF-36)
Time Frame
SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
Title
Kidney function
Description
Creatinine clearance
Time Frame
Before surgery and at three, six and twelve months after surgery
Title
Liver function
Description
ALT, AST
Time Frame
Before surgery and at three, six and twelve months after surgery
Title
Bone turnover markers
Description
Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
Time Frame
At three, six and twelve months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Carlos Gonzalez
Organizational Affiliation
Orthopaedic Department-Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
10884214
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.
Results Reference
background
PubMed Identifier
10037335
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.
Results Reference
background
PubMed Identifier
14630840
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.
Results Reference
background
Learn more about this trial
The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty
We'll reach out to this number within 24 hrs