Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT01358669
Eligibility Criteria:
Inclusion Criteria:
* 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.
* Participants must also be willing and able to give fully informed consent.
* Participants must have osteolysis / aseptic loosening affecting fully cementless, hybrid, or fully cemented THA prosthesis
Exclusion Criteria:
* Known prosthesis infection
* Pregnancy / Breast feeding
* Oral bisphosphonate therapy (current use, previous use within the last 12 months, previous 3 or more years cumulative use)
* Administration of intravenous bisphosphonate, fluoride or strontium within the last 5 years
* Participation in ongoing or previous denosumab clinical trials
* Administration of any of the following treatments within the last 12 months
* TH or PTH derivatives, eg, teriparatide
* anabolic steroids or testosterone
* glucocorticosteroids (\> 5 mg prednisone equivalent per day for more than 10 days)
* systemic hormone replacement therapy
* selective estrogen receptor modulators (SERMs), eg, raloxifene tibolone, calcitonin or calcitriol
* Any subject in whom denosumab is contraindicated according to the local SmPC of denosumab (SC 60 mg every 6 months in UK)
* Current hypocalcemia (albumin adjusted serum calcium below 2.13 mmol/L)
* History of rheumatoid arthritis
* History of Paget's disease
* Malignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
* Renal insufficiency assessed by eGFR \<30
* Known sensitivity to mammalian cell derived drug products
* 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
* 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
* Evidence of alcohol or substance abuse within the last 12 months that the Investigator believes would interfere with understanding or completing the study
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT01358669
Study Brief:
Protocol Section:
NCT01358669