EUCTR2005-002984-10-GB进行中（未招募）1 期
A randomized, double-blind, multi-center, placebo-controlled study to evaluate the efficacy and safety of oral salmon calcitonin in the treatment of osteoporosis in postmenopausal woman taking calcium and vitamin D
ordic Bioscience0 个研究点目标入组 4,500 人开始时间: 2005年11月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,500
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
- •·Postmenopausal, ambulatory women, between 60 and 85 years old
- •·Stratum A (50% of all enrolled subjects): BMD T-score £–2.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip.
- •·Stratum B (50% of all enrolled subjects): BMD T-score £ –1.5 at one or more of the following regions: the lumbar spine, femoral neck or total hip together with osteoporotic fracture(s) located at the spine according the definition of Genant et al (15).
- •·Ethical - Before any study-specific procedure, the appropriate written informed consent must be obtained.
- •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
- •·In different regions of the world different values for the lowest level of BMD T-score and/or number and severity of prevalent vertebral fracture may apply. It will be up to the principal investigator to apply such limits that will satisfy the appropriate local ethical committees or health authorities.
- •·For stratum A: more than 2 vertebral deformities (Genant et al, 15)
- •·The presence of clinical vertebral fracture defined as a vertebral fracture associated with pain or functional disability.
- •·BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or total hip
- •·Evidence of any of the following from medical history, laboratory results, DXA, or X-ray review:
- •oHistory of renal stone
- •oCurrent hyper- or hypothyroidism. Patients on stable thyroid treatment will be allowed
- •oCurrent hyper- or hypoparathyroidism
- •oRheumatoid arthritis
- •oPaget’s disease
- •oMalignancy (except basal cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
- •oAny bone disease, e.g., osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
- •oUntreated or symptomatic malabsorption syndrome
- •oHeight, weight and girth which may preclude accurate DXA measurements
- •oAdvanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment
- •oLess than 2 lumbar vertebrae (L1-L4) evaluable for DXA
- •oScreening 25 (OH) vitamin D level less than 12 ng/mL. The patient may be treated with 50.000 IU oral 25 (OH) vitamin D per day for 2 weeks and serum vitamin D may then be retested. If the level is between 12 and 20 ng/mL, then the subject should be instructed to take at least 800 IU Vitamin D daily.
- •oSerum levels of intact PTH above 65 pg/ml.
- •oCurrent hypocalcaemia (albumin adjusted serum calcium below 2.13 mmol/L [8.5 mg/dL])
- •·Any organic or psychiatric disorder, or 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
- •·Evidence of alcohol or substance-abuse that the investigator believes would interfere with understanding or completing the study
- •·Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- •·Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s).
研究者
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