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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001285-15 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab | Active Comparator | Patients treated with Denosumab |
|
| Placebo | Placebo Comparator | Patients treated with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denosumab | Drug | Denosumab treatment one year after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mass index | Bone Mass index in gr/cm3 | Change in densitometry before surgery (0) and at three (3) months after surgery |
| Change in Bone Mass index | Bone Mass index in gr/cm3 | Change in densitometry before surgery (0) and at six (6) months after surgery |
| Change in Bone Mass index | Bone Mass index in gr/cm3 | Change in densitometry before surgery (0) and at twelve (12) months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (WOMAC) | WOMAC test before (0) and at three (3), six (6) and twelve (12) months after surgery | |
| Quality of life (SF-36) | SF-36 test before (0) and at three (3), six (6) and twelve (12) months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Carlos Gonzalez | Orthopaedic Department-Hospital de la Santa Creu i Sant Pau | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10884214 | Background | 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. | |
| 10037335 | Background | 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. |
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| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Placebo | Drug | Serum one year after surgery |
|
|
| Kidney function | Creatinine clearance | Before surgery and at three, six and twelve months after surgery |
| Liver function | ALT, AST | 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) | At three, six and twelve months after surgery |
| 14630840 | Background | 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. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |