EUCTR2005-005081-37-DE进行中（未招募）不适用
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment withDenosumab versus Alendronate Sodium in Postmenopausal Women with LowBone Mineral Density
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 1,100
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
- Female
入选标准
- •-Ambulatory postmenopausal women based on medical history.
- •-BMD values (g/cm2), assessed at the local site that correspond to T-score = -2.0
- •at the lumbar spine OR total hip as follows:
- •a) For the lumbar spine, the BMD values (g/cm2) must be =0.940 (GE lunar) or =0.827 (Hologic)
- •b) For the total hip, the BMD values (g/cm2) must be =0.756 (GE lunar) or =0.698 (Hologic)
- •-Provide the appropriate written informed consent before any study-specific
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Any disorder that compromises the ability of the subject to give written informed consent and /or comply with study procedures
- •-Evidence of any of the following:
- •a) Hyper- or hypothyroidism
- •b) Current hyper- or hypoparathyroidism
- •c) Elevated transaminases
- •d) Significantly impaired renal function as determined by serum creatinine = 2.0 mg/dL
- •e) Current hypo- or hypercalcemia based on the central laboratory reference ranges
- •f) Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication
- •g) Rheumatoid Arthritis, Paget’s disease, Cushing’s disease, hyperprolactinemia, or cirrhosis of the liver
- •h) Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
- •i) Malignancy (except fully resected cutaneous basal cell or squamous cell
- •carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
- •j) Any metabolic bone disease, eg, osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
- •k) Malabsorption syndrome or any gastrointestinal disorders that are associated
- •with malabsorption
- •-Received any solid organ or bone marrow transplant.
- •-Vitamin D deficiency (25(OH) vitamin D level < 12 ng/mL).
- •-Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results.
- •-Contraindicated or poorly tolerant of ALN therapy.
- •-Known sensitivity to mammalian cell derived drug products.
- •-Known intolerance to calcium supplements.
- •-Administration of intravenous bisphosphonate, or fluoride (except for dental
- •treatment) or strontium ranelate.
- •-Oral bisphosphonate treatment:
- •= 3 months cumulatively in the past 2 years, OR
- •= 1 month in the past year, OR
- •Any use during the 3-month period prior to randomization
- •-PTH or PTH derivatives (eg, teriparatide) within the last year.
- •-Administration of any of the following treatments within 3 months of randomization:
- •a) Any SERM (eg, raloxifene)
- •b) Tibolone
- •c) Anabolic steroids or testosterone
- •d) Glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10
- •e) Systemic (oral, transdermal, topical) hormone replacement therapy (local
- •vaginal estrogen preparation will be allowed)
- •f) Calcitonin
- •g) Calcitriol or vitamin D derivatives
- •h) Other bone active drugs including anti-convulsives (except benzodiazepines)
- •and heparin
- •i) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum,
- •lithium, protease inhibitors, methotrexate, gonadotropin-releasing hormone
- •-Height, weight or girth which may preclude accurate DXA measurements.
- •-Less than 2 lumbar vertebrae (L1-L4) evaluable for DXA measurements.
- •-Both hips not evaluable by DXA (eg, history of bilateral hip replacement or pins in
- •both hips).
- •-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.
- •-Any physical or psychiatric disorder which, in the opinion of the investigator, will
- •prevent the subject from completing the study or interfere with the interpretation
- 另有 3 项未显示
研究者
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