EUCTR2005-002984-10-IT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 Calcitonin in the Treatment of Postmenopausal Women Taking Calcium and Vitamin D. - ND
ORDIC BIOSCIENCE0 个研究点目标入组 4,500 人开始时间: 2007年4月23日最近更新:
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 61603; 2.5 at one or more of the following regions the lumbar spine, femoral neck or total hip. The inclusion will be defined by the absolute BMD values g/cm2 given in Section 8.13.1. These subjects will have no prevalent vertebral fractures. OR Stratum B 50 of all enrolled subjects BMD T-score 61603; 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 to the definition of Genant et al 15 . The inclusion will be defined by the absolute BMD values g/cm2 given in Section 8.13.1. Ethical criterium - before any study-specific procedure is performed, 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) no
- •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 participant will be excluded from the study, if they have a bone mineral density BMD T-score below 4.0 based on absolute values g/cm2 as given in the protocol at one or more of the measured sites. Any participant will be excluded from the study, if they have more than 2 prevalent moderate and/or severe vertebral fractures Genant et al, 15 . If BMD is lower than -2.5 T-score at one or more of the measured sites, the participants will be excluded from the study, if they have a severe vertebral fracture Genant et al, 15 . Participants will be excluded from the study, if they have evidence of any clinical osteoporotic fracture and/or if they have a history of a clinical osteoporotic fracture excluding wrist fractures . A clinical vertebral fracture is defined as 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 o History of renal stone o Current hyper- or hypothyroidism. Patients on stable thyroid treatment will be allowed o Current hyper- or hypoparathyroidism o Rheumatoid arthritis o Paget s disease o Malignancy except basal cell carcinoma, cervical or breast ductal carcinoma in situ within the last 5 years o Any bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings o Untreated or symptomatic malabsorption syndrome o Height, weight and girth which may preclude accurate DXA measurements o Advanced scoliosis or extensive lumbar fusion which would preclude vertebral fracture assessment o Less than 2 lumbar vertebrae L1-L4 evaluable for DXA for the BMD substudy population . Subjects that fulfil the BMD inclusion criteria at the hip, and are not enrolled in the BMD substudy, may be enrolled even if there are not 2 evaluable lumbar vertebrae. o Screening 25 OH vitamin D level less than 12 ng/mL. The patient may be treated with 50,000 IU of 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 of vitamin D daily o Serum levels of intact PTH above 65 pg/ml o Current 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. Subjects with any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. The subject is currently enrolled in a clinical study or at least 30 days have not elapsed since ending other investigational device or drug trial s .
研究者
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