A clinical trial to find out whether a medication, called denosumab, has an effect on the bone surrounding a hip joint replacement

• Conditions: Prosthesis-related osteolysis after total hip arthroplasty; MedDRA version: 14.0Level: LLTClassification code 10057128Term: Revision of hip arthroplastySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-000541-20-GB
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified