ncemented total hip implant and subcutaneous injection of Denosumab for patients with degenerative joint disease of the hip. A randomised double blind placebo controlled study on the effects on bone evaluated with bone densitometry, uptake of Fluoride isotop measure with Positron Emission Tomography and Computed Tomography, and blood samples analyzed for bone turnover.
- Conditions
- 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 implantsTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2011-001481-18-SE
- Lead Sponsor
- ppsala University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 64
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 <110 kg or 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
Demographic history, age, sex, height and weight, medical history, physical examination should be recorded and checked for inclusion as well as exclusion criterias.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 <35ml/min, calcultated according to Cockcroft-Gault, must not be included in the study.
5.Patients with compromised general conditions and an American Society of Anesthesiologists, ASA-score >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br>•evaluate the safety and tolerability of Denosumab in patients with total hip arthroplasty<br>•evaluate quality of life after treatment with Denosumab in patients with total hip arthroplasty<br>;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 Outcome Measures
Name Time Method