Patients with osteoarthritis of the hip treated with an uncemented total hip arthroplasty. This procedure is accompanied with an increased risk for loss of bone adjacent to the implants
Conditions
Interventions
Trade Name: Prolia
Product Name: Prolia
Pharmaceutical Form: Solution for injection in pre-filled pen
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo:
Sponsors
Uppsala University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients must fulfil the following criterias to included 1. Male or female patients patients 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip, 2. Body weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following criteria will exclude the patient from participating in the study: 1. on or previously have had bone-specific treatment, eg bisphophonates, raloxiphene, parathyroid hormone, strontium ranelate, during the last five years 2. patients on systemical corticosteroid for more than 3 months should not be considered.. 3. patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded. 4. Patients with renal insufficiency and a se-creatinine-clearance 31 should not be regarded eligible. 6. Patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study. 7. Pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study. 8. Patients that have been exposed frequently and/or have had large irradiation doses, as jugded by the investigator, must not be included in the study. 9. 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. 10. Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.;Secondary Objective: The secondary objectives are to: • evaluate the safety and tolerability of Denosumab in patients with total hip arthroplasty • evaluate quality of life after treatment with Denosumab in patients with total hip arthroplasty ;Primary end point(s): 1. BMD, g/cm2, adjacent to the femur implant, Gruen zone 7, and the sum for all Gruen zones after 12 months;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Fluoride isotope uptake, measured as Standardized Uptake Values, adjacent to the femoral stem, 3 and 6 months after surgery and longitudinal changes during the period after surgery. 2. The study drug’s effects on SUV measured with PET/CT adjacent to the acetabular cup after 3 and 6 months and longitudinal changes during the period after surgery. 3. The study drugs effect on BMD adjacent to the acetabular cup during the follow up period, ie after 3,6, 12 and 24 months 4. The study drug’s effects on biochemical markers for bone turnover and the relation to PET and BMD findings at the proximal femur and acetabulum during the follow up period, ie after 3,6, 12 and 24 months 5. The study drug’s effects on BMD at the lumbar spine and at the contra lateral hip after surgical treatment with an uncemented THA after 12 months (and 24 and 60 months) 6. The study drug’s effects on biochemical markers for bone turnover and the relation to PET and BMD findings at anatomical sites not exposed to surgery, ie the lumbar spine and the contra lateral hip after 3 and 6 months 7. The natural course of an uncemented THA on SUV measured with PET, ie the placebo group after 3 and 6 months (and 24 months) 8. The natural course of an uncemented THA on biochemical markers, ie the placebo group after 3, 6 and 12 months. 9. The study drug’s effect on SUV at the lumbar spine and at the contra lateral hip after surgical treatment with an uncemented THA after 3 and 6 months 10. Patients Quality of Life, measured by Harris Hip score and EQ-5D questionnaires. 11. To evaluate incidence and severity of adverse events during the study period ;Timepoint(s) of evaluation of this end point: 3,6,12,24 months | — |
Countries
Sweden
Contacts
Public ContactHans Mallmin
Uppsala University
Outcome results
None listed