A Phase 4 interventional study of Denosumab and Placebo in Bone Resorption, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2017-08-11.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 4, Interventional, and Prevention
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.
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.
153 studies on the registry are indexed under Bone Resorption; 25 are open to participants now.
This study's enrollment of 60 is above the median of 22 across 133 interventional studies indexed under Bone Resorption.
Browse Bone Resorption studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated with Denosumab
Drug: Denosumab
Patients treated with placebo
Drug: Placebo
Denosumab treatment one year after surgery
Also known as: Prolia
Serum one year after surgery
Also known as: Serum
Change in Bone Mass index
Bone Mass index in gr/cm3
Time frame: Change in densitometry before surgery (0) and at three (3) months after surgery
Change in Bone Mass index
Bone Mass index in gr/cm3
Time frame: Change in densitometry before surgery (0) and at six (6) months after surgery
Change in Bone Mass index
Bone Mass index in gr/cm3
Time frame: Change in densitometry before surgery (0) and at twelve (12) months after surgery
Quality of Life (WOMAC)
Time frame: WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery
Quality of life (SF-36)
Time frame: SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery
Kidney function
Creatinine clearance
Time frame: Before surgery and at three, six and twelve months after surgery
Liver function
ALT, AST
Time frame: Before surgery and at three, six and twelve months after surgery
Bone turnover markers
Beta cross lap and Procollagen type 1 n-terminal propeptide (P1NP)
Time frame: At three, six and twelve months after surgery
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau