A Phase 2 interventional study of denosumab in Osteoarthritis, Hip and Ambulation Difficulty, sponsored by Hans Mallmin. Completed at 1 site in Sweden. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-04-05.
Sponsored by Hans Mallmin · Phase 2, Interventional, and Prevention
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 64 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →This is the only study on the registry with Hans Mallmin as lead sponsor.
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Exclusion Criteria:
1 ml (60 mg) subcutaneous injection Denosumab give in the posterior part of the upper arm after surgery followed by another injection 6 months later
Drug: denosumab
1 ml subcutaneous injection 0.9% saline give in the posterior part of the upper arm after surgery followed by another injection 6 months later
Drug: denosumab
Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval
Also known as: Prolia
Bone Mineral Density
Bone mineral density by DXA in Gruen Zone 7 and a sum of Gruen zone 1-7
Time frame: 12 months
Bone mineral Density
BMD, g/cm2, adjacent to the femur implant for Gruen Zone 1-7, 3, 6, and 24 months after surgery
Time frame: 24 months
Standardised Uptake value
fluoride isotope uptake, measured as (SUV), adjacent to the femoral stem, 3 and 6 months after surgery.
Time frame: 6 months
Standardised Uptake value
fluoride isotope uptake, measured as SUV adjacent to the acetabular cup 3 and 6 months after surgery
Time frame: 6 months
Bone Mineral density
BMD adjacent to the acetabular cup during the follow up period, i.e. after 3, 6, 12 and 24 months
Time frame: 24 months
Bone Mineral Density
BMD at the lumbar spine and at the contra lateral nonoperated hip 6, 12 and 24 months after surgery
Time frame: 24 months
Standardised Uptake Value
Fluoride isotope uptake measured as SUV at the lumbar spine and at the contra lateral nonoperated hip after 3 and 6 months
Time frame: 6 months
Biochemical markers for bone metabolism
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
Time frame: 24 months
Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value
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
Time frame: 24
Biochemical markers for bone metabolism in relation to Bone Mineral Density and Standardised Uptake Value
to evaluate the natural course of an uncemented THA on BMD, i.e. the placebo group 3, 6, 12 and 24 months after surgery, SUV i.e. the placebo group 3 and 6 months after surgery and on biochemical markers, i.e. the placebo group 3, 6, 12 and 24 months after surgery
Time frame: 24
Clinical outcome evaluation
to evaluate the patients Quality of Life, measured by Harris Hip score and EQ-5D questionnaires
Time frame: 24 months
Adverse events
incidence and severity of adverse events (AEs) during the study period
Time frame: 24 months
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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