EUCTR2011-000541-20-GBActive, not recruitingNot Applicable
Effect of Denosumab on Osteolytic Lesion Activity in Total Hip Arthroplasty (THA) - Effect of Denosumab on Osteolytic Lesion Activity in THA
Sheffield Teaching Hospitals NHS Foundation Trust0 sites30 target enrollmentStarted: June 30, 2011Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Participants must be men or women over 30 years of age undergoing revision THA surgery for periprosthetic osteolysis / aseptic loosening affecting the pelvis and / or femur.
- •2. Participants must also be willing and able to give fully informed consent.
- •3. Participants must have osteolysis / aseptic loosening affecting fully cementless, hybrid, or fully cemented THA prosthesis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •The following exclusion criteria will apply:
- •1. Known prosthesis infection
- •2. Pregnancy / Breast feeding
- •3. Oral bisphosphonate therapy (current use, previous use within the last 12 months, previous 3 or more years cumulative use)
- •4. Administration of intravenous bisphosphonate, fluoride or strontium within the last 5 years
- •5. Participation in ongoing or previous denosumab clinical trials
- •6. Administration of any of the following treatments within the last 12 months
- •7. PTH or PTH derivatives, eg, teriparatide
- •8. anabolic steroids or testosterone
- •9. glucocorticosteroids (> 5 mg prednisone equivalent per day for more than 10 days)
- •10. systemic hormone replacement therapy
- •11. selective estrogen receptor modulators (SERMs), eg, raloxifene tibolone, calcitonin or calcitriol
- •12. Any subject in whom denosumab is contra-indicated according to the local SmPC of denosumab (SC 60 mg every 6 months in UK)
- •13. Current hypocalcemia (albumin adjusted serum calcium below 2.13 mmol/L)
- •14. History of rheumatoid arthritis
- •15. History of Paget’s disease
- •16. Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma
- •in situ) within the last 5 years
- •17. Renal insufficiency assessed by eGFR <30
- •18. Known sensitivity to mammalian cell derived drug products
- •19. Any organic or psychiatric disorder, or laboratory abnormality which, in the opinion of the Investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
- •20. Any disorder that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
- •21. Evidence of alcohol or substance-abuse within the last 12 months that the Investigator believes would interfere with understanding or completing the study
- •22. Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
Investigators
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