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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.
This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclasta | Experimental | Aclasta IV once annual for 2 years |
|
| Placebo | Placebo Comparator | Placebo group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclasta | Drug | Aclasta once annually for 2 years |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| bone mineral density [g/cm2] of the 7 Gruen zones | bone mineral density measured by dual energy x-ray absorptiometry | 5 years |
| bone mineral density change relative to the baseline values of the 7 Gruen zones | bone mineral density measured by dual energy x-ray absorptiometry | 5 years |
| implant loosening or migration | check the implant position by serial standard X ray follow-up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| serum alkaline phosphatase | 5 years | |
| serum calcium level | 5 years | |
| serum phosphate level |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Kweishan | Taoyuan | 333 | Taiwan |
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| Label | URL |
|---|---|
| Chang Gung Memorial Hospital | View source |
| American Academy of Orthopaedic Surgeons | View source |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Drug |
No IV aclasta |
|
| 5 years |
| serum osteocalcin level | 5 years |
| serum N-telopeptide procollagen level | 5 years |
| serum creatinine level | renal function and glomerular filtration rate | 5 years |
| serum alanine aminotransferase level | liver function | 5 years |
| serum aspartate aminotransferase level | liver function | 5 years |
| harris hip score | hip function measurement | 5 years |
| short form-12 | life quality measurement | 5 years |
| University of California Los Angeles Activity Score | functional and activity evaluation, 10 point scale | 5 years |
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |