Effects of Denosumab on Periprosthetic Bone After Total Hip Arthroplasty

A clinical study with 64 patients, age 35-65 years, with unilateral osteoarthritis of the hip, randomised to two groups of patients, either receiving Denosumab or placebo

The patients will operated with an uncemented total hip arthroplasty with a Continuum acetabular cup with trabecular surface (Tantalum) and longevity Highly Cross-linked Polyethylene liner, Zimmer, Warsaw, IN, USA, and a CFP femoral stem with Titanium surface and a chrome cobalt 28 mm head, Waldemar Link, Hamburg, Germany.

Clinical outcome evaluated by Harris Hip Score and EQ-5D, Bone Mineral Density by DXA, Standardised Uptake Value of Fluoride tracer, by PET/CT and biochemical markers for bone formation and bone resorption will be analyzed together with conventional radiology for implant position and fixation.

Inclusion criteria

• male or female patient 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip
• body weight ≤110 kg or body mass index (BMI) ≤35 kg/m2
• living in the Uppsala County
• the eligible patients should have been given oral information, a written Patient Information and signed an Informed Consent

Exclusion criteria

• on or previously have had bone-specific treatment, e.g. bisphosphonates, raloxifene, parathyroid hormone, strontium ranelate, during the last five years
• patients on systemical corticosteroid for more than 3 months should not be considered
• patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded
• patients with compromised general conditions and an American Society of Anesthesiologists, ASA-score >31 should not be regarded eligible
• patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study
• pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study
• patients that have been exposed frequently and/or have had large irradiation doses, as judged by the investigator, must not be included in the study.
• enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study
• any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion (for example claustrophobia)