EUCTR2011-001481-18-SE进行中（未招募）1 期
ncemented total hip implant and subcutaneous injection of Denosumab for patients with osteoarthritis of the hip. A randomised double blind placebo controlled study on the effects on bone evaluated with DXA, PET/CT, and biochemical markers. - DATA
ppsala University Hospital0 个研究点目标入组 64 人开始时间: 2011年8月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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