EUCTR2013-004940-48-SE进行中（未招募）1 期
Denosumab For Treating Periprosthetic Osteolysis After Uncemented Total Hip Arthroplasty. A randomized, double-blind, placebo-controlled trial using volumetric computed tomography.
Danderyds Hospital, Department of Clinical Sciences, Division of Orthopaedics0 个研究点目标入组 110 人开始时间: 2014年10月3日最近更新:
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
- 110
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
- •Age 40-85 years
- •Short Portable Mental Status Questionnaire (SPMSQ) also named Pfeiffertest =7 correct responses or alternatively = 3 incorrect responses
- •Male and females
- •The primary THA performed at least 7 years before inclusion.
- •The primary THA performed due to osteoarthritis or congenital dysplasia of the hip.
- •Uncemented cup fixation
- •Baseline osteolytic lesion of at least 2 cm³ and at most 40 cm³ around an uncemented acetabular component with a polyethylene liner.
- •Participant is willing and able to follow study protocol and has provided informed consent prior to any study specific procedures.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Women that are pregnant or women planning to become pregnant or planning to breastfeed
- •For women of childbearing potential (menopausal state -determined??): Subject refuses to use 1 highly effective method of contraception (contraceptive pill, intra uterine contraceptive device) for the duration of the study and for 5 months after the last dose of study medication.
- •For women of childbearing potential: Subject refrain from breastfeeding for the duration of the study and for 5 months after the last dose of study medication.
- •For males with a partner of childbearing potential: Subject refuses to use a condom for the duration of the study and for 5 months after the last dose of study medication.For males with a partner who is pregnant: Subject refuses to use a condom for the duration of the study and for 5 months after the last dose of study medication.
- •Women that are pregnant or breastfeeding or women planning to become pregnant or planning to breastfeed.
- •Pain in the operated hip (because the presence of hip pain in combination with an osteolytic lesion is an indication for revision surgery) as defined by a visual analog scale (VAS) score >3
- •Previous revision surgery of the hip i.e. exchange of any inplant after the primary surgery
- •Inflammatory arthritis
- •Previous participation in clinical trials with denosumab or administration of commercial denosumab (Prolia™ or Xgeva™)
- •Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
- •Treatment with any intravenous bisphosphonate, fluoride (except for dental treatment) or strontium ranelate within 5 years prior to inclusion.
- •Treatment with any oral bisphosphonate within 1 year prior to inclusion.
- •Treatment with cortisol or cytostatic drugs within 6 months prior to inclusion.
- •Administration of any of the following treatments 3 months prior to screening:
- •Anabolic steroids or testosterone
- •Glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of = 50 mg)
- •Calcitriol or vitamin D derivatives [vitamin D contained in supplements or multivitamins is allowed]
- •Other bone active drugs including anti-convulsives (except benzodiazepines, gabapentin and pregabalin) and heparin
- •Chronic systemic ketoconazole, ACTH (adrenocorticotrophic hormone), cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone agonists.
- •Androgen deprivation therapy
- •Hypocalcaemia.
- •Bone metabolic disorders (such as OI, PHPT, Paget)
- •History of osteonecrosis of the jaw and/or recent (within prior 6 months) tooth extraction or dental surgery; or planned invasive dental proceedures during the study
- •Serum 25-OH D <15 ng/ml
- •Significant malabsorption including Celiac Disease, Short Bowel Syndrome, Crohn’s Disease, Previous Gastric Bypass.
- •Active cancer and/or malignancy in last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- •History of solid organ or bone marrow transplant.
- •Hypersensitivity to any components of study drug.
- •Intolerance to calcium supplements.
- •Pregnancy and/or currently lactating.
- •Significantly impaired renal function as determined by a derived glomerular filtration rate (GFR) using Cockcroft Gault formula of ? 30 mL/min/1.73 m2
- •Elevated transaminases = 2.0 x upper limit of normal (ULN); Elevat
研究者
相似试验
Unknown
2 期
Denosumab for Treating Periprosthetic Osteolysis.OsteolysisNCT02299817Olof Skoldenberg20
已完成
不适用
Denosumab prevents periprosthetic bone mineral density loss in the tibial metaphysis in total knee arthroplastyPrimary osteoarthritis of kneeJPRN-UMIN000035653Department of Orthopaedic Surgery, Sapporo Medical University School of Medicine28
尚未招募
不适用
Denosumab in hemodialysis patients with osteoporosis : comparison of usefullness between high and low turnover bone.osteoporosisJPRN-UMIN000011999Sato Junkanki hospital50
已完成
不适用
The effect of denosumab for the treatment of osteoporosis in hemodialysis patientsOsteoporosisJPRN-UMIN000014458Saiseikai Kumamoto Hospital40
已完成
不适用
Effects of denosumab on the treatment of osteoporosis and inhibition of bone erosion in rheumatoid arthritisRheumatoid ArthritisJPRN-UMIN000042107Department of Orthopedic Surgery, Tohoku University Graduate School of Medicine200