EUCTR2005-005598-30-FR进行中（未招募）不适用
A NON-INVASIVE EVALUATION OF BONE MICROARCHITECTURE MODIFICATION IN OSTEOPENIC POSTMENOPAUSAL WOMEN BY 3D-PERIPHERAL QUANTITATIVE COMPUTED TOMOGRAPHY : A 24-MONTH, MONOCENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY COMPARING WEEKLY ORAL RISEDRONATE 35 MG AND PLACEBO - OSMAUSE
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Women meeting all of the following criteria are eligible for randomization into the study:
- •a)ambulatory ;
- •b)between 55 and 75 years of age, inclusive ;
- •c)spontaneous cessation of menstruation since at least 12 months prior to study enrollment
- •d)has osteopenia defined as having the following :
- •Lumbar spine (L1 through L4)
- •BMD T-score of -1 to -2.5
- •Hologic: 0.937 g/cm2 to 0.772 g/cm2
- •Lunar:1.060 g/cm2 to 0.882 g/cm2
- •A total hip T-score of >ou =-2.5
- •Hologic: >ou= 0.636 g/cm2
- •Lunar: >ou= 0.693 g/cm2
- •Lumbar spine (L1 through L4)
- •BMD T-score of >ou=-2.5
- •Hologic: >ou= 0.772 g/cm2
- •Lunar: >ou= 0.880 g/cm2
- •A total hip T-score of -1 to -2.5
- •Hologic: 0.819 g/cm2 to 0.636 g/cm2
- •Lunar: 0.881 g/cm2 to 0.693 g/cm2
- •e)must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
- •f)BMI <30 kg/m2 inclusive ;
- •g)in generally good health as determined by medical history, physical examination, and laboratory tests ; and
- •h)are willing and able to participate in the study and to provide written informed consent.
- •Are the trial subjects under 18?
- •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
- •Patients will not be admitted into the study if they exhibit any of the following :
- •a)documented history of illicit drug abuse or alcohol abuse (for the past 2 years) ;
- •b)evidence of significant psychiatric or organic disease (particularly a history of malignant disease [excluding skin epitheliomas], gastrointestinal, hepatic, renal, or cardiac disease), which, in the opinion of the investigator and the medical monitor, would prevent the patient from completing the study ;
- •c)history of tremor disorder ;
- •d)history of recent (<6 months) primary hyperparathyroidism or recent thyroid disorder ;
- •e)history of any generalized bone disease, including progressive hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease, or any known condition that would interfere with the assessment of DXA at either the lumbar spine (>ou= 3 non-evaluable lumbar vertebrae at lumbar spine L1 – L4) or the femoral neck ;
- •f)clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (>ou= 20% reduction in anterior-to-posterior or middle-to-posterior height ratio ; or >ou= 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X-ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist ;
- •g)glucocorticoid-induced osteopenia ;
- •h)previous IV bisphonate therapy
- •i)oral bisphosphonate therapy for > 3 months in the past 3 years ;
- •j)use of estrogens and/or progestins for > 1 month at any time within the past 12 months ;
- •k)use of any of the following medications for > 1 month at any time within the past 6 months :
- •-corticosteroids or anabolic medications,
- •-calcitonin,
- •-vitamin D (>ou= 1000 IU/day), or
- •-diuretics if not stable since at least 3 months
- •-anticonvulsants ;
- •l)use of fluoride (prescribed in the bone therapeutic range of >ou= 10 mg/day) for > 1 month ;
- •m)current use of any of the following medications :
- •-oral or parenteral glucocorticoids,
- •-anabolic steroids,
- •-estrogens (oral, skin patch, gel, or subcutaneous implant),
- •-estrogen-related medications, such as tamoxifene, selective estrogen receptor modulators (raloxifene), tibolone
- •-progestins,
- •-calcitonin, calcitriol, calcifediol, or alfacalcidol
- •-calcium supplements (> 1g/day)
- •-vitamin D supplements (> 800 IU/day)
- •-vitamin D depot injection (>10,000 IU)
- •-any bisphosphonate (other than the investigational product) used for > 1 month at any time within the past 6 months,
- •-fluoride (>ou= 10 mg/day),
- •-strontium and other bone active agents (ie isoflavones),
- •-PTH at any time within the past 3 years ; or
- •-any other investigational product
- •n)history of any allergic or abnormal reaction to bisphosphonates ;
- •o)severe renal impairment (creatinine clearance < 30mL/min) ;
- •p)serum 25-hydroxy vitamin D level < 15 ng/mL
- •q)markedly abnormal clinical laboratory parameters at screening assessed as clinically significant by the investigator;
- •r)participation in another clinical study 30 days prior to enrollment ;
- •s)demonstrated unlikely to comply with protocol requirements (eg, uncooperative attitude, inability to return for follow-up visits, history of medical non-compliance) and/or poor likelihood of completing the study.
研究者
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