Functional Outcomes, Prevention of BMD Loss After THR, Serum Markers of Bone Turnover
Conditions
Keywords
bisphosphonate, Total hip replacement, functional outcomes, bone mineral density
Brief summary
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.
Detailed description
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.
Interventions
DRUGAclasta
Aclasta once annually for 2 years
DRUGPlacebo
No IV aclasta
Sponsors
Novartis
Mel Shiuann-Sheng Lee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female,between 35 and 85 years of age 2. Indicated for Total hip replacement for various hip diseases 3. Has preoperative DXA study within 3 months before the total hip replacement procedure or willing to receive preoperative DXA study as a baseline comparison 4. Signed written informed consent 5. Standard transgluteal approach for total hip replacement using Zimmer Triology Cup and Versys Fiber Metal Taper Stem with metal to highly cross-linked polyethylene bearing surface
Exclusion criteria
1. Any prior use of intravenous bisphosphonate within the last 2 years 2. Uncontrolled seizure disorders associated with falls 3. A history of invasive malignancy of any organ system, treated or untreated, within the past five years; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed 4. Carcinoma in situ of the uterine cervix 5. History of osteogenesis imperfecta, multiple myeloma, or Paget's disease 6. Active primary hyperparathyroidism 7. History of iritis or uveitis 8. Self-reported history of diabetic nephropathy or retinopathy 9. AST or ALT more than twice the upper limit of normal 10. Alkaline phosphatase more than twice the upper limit of normal 11. Serum calcium 2.75 mmol/L (11.0 mg/dL) 12. Baseline renal insufficiency (calculated creatinine clearance 35 ml/min) 13. History of hypersensitivity to bisphosphonates 14. Use of any investigational drug(s) and/or devices within 30 days prior to randomization 15. Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the Protocol or completing the trial per protocol 16. Use of hip protectors 17. With implant or prosthesis on the contralateral hip joint
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density change relative to the baseline values of the 7 Gruen zones | 5 years | bone mineral density measured by dual energy x-ray absorptiometry |
| implant loosening or migration | 5 years | check the implant position by serial standard X ray follow-up |
| bone mineral density [g/cm2] of the 7 Gruen zones | 5 years | bone mineral density measured by dual energy x-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum osteocalcin level | 5 years | — |
| serum N-telopeptide procollagen level | 5 years | — |
| serum creatinine level | 5 years | renal function and glomerular filtration rate |
| serum alanine aminotransferase level | 5 years | liver function |
| serum alkaline phosphatase | 5 years | — |
| harris hip score | 5 years | hip function measurement |
| short form-12 | 5 years | life quality measurement |
| University of California Los Angeles Activity Score | 5 years | functional and activity evaluation, 10 point scale |
| serum aspartate aminotransferase level | 5 years | liver function |
| serum calcium level | 5 years | — |
| serum phosphate level | 5 years | — |
Countries
Taiwan
Outcome results
None listed