JPRN-jRCTs031210187进行中（未招募）未知
Assessment of patient satisfaction with self-administration of teriparatide for primary osteoporosis patients
Soen Satoshi0 个研究点目标入组 400 人开始时间: 2021年7月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 60age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Eligible patients are those who have given written consent to participate in the study and meet all of the inclusion criteria listed below:
- •(1) Diagnosed with primary osteoporosis according to the diagnostic criteria of the Japanese Society for
- •Bone and Mineral Research (year 2012 revision)
- •(2) Japanese aged 60 years and older at the time of consent
- •(3) Postmenopausal women
- •(4) Able to visit a hospital for treatment
- •(5) Able to self-administer medications
- •(6) Able to comprehend and answer the contents of the patient questionnaire
- •(7) Patients who meet any of the following conditions:
- •1 Less than 60% or -3.3SD of YAM in bone density
- •2 Have more than 2 vertebral body fractures between the fourth thoracic vertebrae (Th4) and the fourth
- •lumbar vertebrae (L4)
- •3 Have grade 3 bone fractures
- •4 Have 1 or more vertebral body fractures between the fourth
- •thoracic vertebrae (Th4) and the fourth lumbar vertebrae (L4), with less than -2.5 SD of YAM in bone density
- •5 Have a history of proximal thighbone fracture
排除标准
- •Patients who meet any of the following criteria will be excluded from participating in the study:
- •(1) Diagnosed with secondary osteoporosis caused by below-listed disorders:
- •1 Endocrine disorders: hyperparathyroidism, hyperthyroidism, juvenile gonadal failure, early menopause,
- •cushings syndrome
- •2 Nutritional disorders: malabsorption syndrome, postgastrectomy, anorexia nervosa, hypervitaminosis
- •A or D, vitamin C deficiency
- •3 Medication: steroid, sex hormone lowering drug, Selective Serotonin Reuptake Inhibitor (SSRI), other
- •drugs (Warfarin, Methotrexate, Heparin, etc.)
- •4 Immobility: systemic immobility (best rest, paraplegia, disuse syndrome, space travel), local immobility
- •(after bone fracture, etc.)
- •5 Congenital disorders: osteogenesis Imperfecta, Marfans syndrome
- •6 Other disorders: rheumatoid arthritis, diabetes, chronic kidney disease (CKD), hepatic disorders, alcohol
- •dependence syndrome
- •(2) Diagnosed with below-listed disorders causing a decrease in bone mass, other than osteoporosis,:
- •1 Osteohalisteresis
- •2 Bone metastasis
- •3 Multiple myeloma
- •4 Vertebral hemangioma
- •5 Pott disease
- •6 Vertebral osteomyelitis
- •(3) Likely to develop hypersensitive reactions such as bronchial asthma, rash (erythema, pomphus, etc.)
- •(4) Patients with contraindications for use of teriparatide acetate
- •(Excerpts from package insert of teriparatide):
- •1 Patients at increased baseline risk of osteosarcoma with:
- •a. Pagets disease of bone
- •b. Unexplained elevations of alkaline phosphatase
- •c. Pediatric and young adult patients with open epiphyses
- •d. Prior radiation therapy involving the skeleton
- •2 Hypercalcemia
- •3 Primary bone cancer or bone metastasis
- •4 Metabolic bone disease other than osteoporosis (hyperparathyroidism, etc.)
- •5 Prior hypersensitive reactions to teriparatide
- •6 Pregnant or suspected of being pregnant
- •(Excerpts from package insert of genetically engineered versions of teriparatide)
- •1 Patients at increased baseline risk of osteosarcoma with:
- •a. Pagets disease of bone
- •b. Unexplained elevations of alkaline phosphatase
- •c. Pediatric and young adult patients with open epiphyses
- •d. Prior radiation therapy involving the skeleton
- •2 Hypercalcemia
- •3 Primary bone cancer or bone metastasis
- •4 Metabolic bone disease other than osteoporosis (hyperparathyroidism, etc.)
- •5 Prior hypersensitive reactions to teriparatide
- •6 Pregnant or suspected of being pregnant
- •(5) Serious kidney disease, hepatic disease, or cardiac disease
- •1 Kidney disease: serum creatinine level >= 2mg/dL
- •2 Hepatic disease: AST(GOT) or ALT(GPT) level is more than 2.5 times the upper limit of the baseline, or
- •more than 100 IU/L
- •3 Cardiac disease: cases corresponding to Grade 2 or higher as defined in Concerning classification criteria for seriousness of adverse drug reactions of medical agents
- •(6) Unable to self-administer medications
- 另有 6 项未显示
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