Ambulation Difficulty, Osteoarthritis, Hip
Conditions
Keywords
Osteoarthritis of the hip, Uncemented Total Hip Arthroplasty, DXA, BMD, PET, CT, Biochemical bone markers
Brief summary
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.
Detailed description
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.
Interventions
DRUGdenosumab
Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval
Sponsors
Hans Mallmin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. male or female patient 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip 2. body weight ≤110 kg or body mass index (BMI) ≤35 kg/m2 3. living in the Uppsala County 4. the eligible patients should have been given oral information, a written Patient Information and signed an Informed Consent
Exclusion criteria
1. on or previously have had bone-specific treatment, e.g. bisphosphonates, raloxifene, 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 compromised general conditions and an American Society of Anesthesiologists, ASA-score \>31 should not be regarded eligible 5. patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study 6. pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study 7. 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. 8. 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 9. any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion (for example claustrophobia)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Mineral Density | 12 months | Bone mineral density by DXA in Gruen Zone 7 and a sum of Gruen zone 1-7 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone mineral Density | 24 months | BMD, g/cm2, adjacent to the femur implant for Gruen Zone 1-7, 3, 6, and 24 months after surgery |
| Standardised Uptake value | 6 months | fluoride isotope uptake, measured as (SUV), adjacent to the femoral stem, 3 and 6 months after surgery. |
| Bone Mineral density | 24 months | BMD adjacent to the acetabular cup during the follow up period, i.e. after 3, 6, 12 and 24 months |
| Bone Mineral Density | 24 months | BMD at the lumbar spine and at the contra lateral nonoperated hip 6, 12 and 24 months after surgery |
| Biochemical markers for bone metabolism | 24 months | biochemical markers for bone turnover and the relation to SUV and BMD findings at the proximal femur and acetabulum during the follow up period, i.e. 3, 6, 12 and 24 months after surgery |
| Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value | 24 | biochemical markers for bone turnover and the relation to SUV and BMD findings at anatomical sites not exposed to surgery, i.e. the lumbar spine and the contra lateral hip 3 and 6 months after surgery |
| Clinical outcome evaluation | 24 months | to evaluate the patients Quality of Life, measured by Harris Hip score and EQ-5D questionnaires |
| Adverse events | 24 months | incidence and severity of adverse events (AEs) during the study period |
| Standardised Uptake Value | 6 months | Fluoride isotope uptake measured as SUV at the lumbar spine and at the contra lateral nonoperated hip after 3 and 6 months |
Countries
Sweden
Outcome results
None listed