JPRN-jRCT2080222852已完成3 期
ED-71 clinical Study Using Alfacalcidol as the Comparator on Bone Mineral Density in Patients With Primary Osteoporosis
CHUGAI PHARMACEUTICAL CO., LTD0 个研究点目标入组 265 人开始时间: 2015年5月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 265
研究概览
简要总结
This is a randomized, double-blind, active comparator trial. 265 Chinese osteoporotic patients were randomly assigned to receive 0.75 mcg eldecalcitol or 1.0 mcg alfacalcidol for 12 months, Lumbar BMD increased by 2.05% higher in eldecalcitol than alfacalcidol group at 12 months. The incidence of adverse events was not different between the two groups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •Each subject must have met all of the following inclusion criteria to be the subject in this study:
- •1) By dual energy X ray absorptiometry (DXA) for the lumbar spine at screening, patients with primary osteoporosis meet the following criteria.
- •Patients with history of fragility fracture*, T score of the bone mineral density of the lumbar spine (L1-4 BMD) is -1.0 SD** or less
- •Patients without history of fragility fracture, T score of the bone mineral density of the lumbar spine (L1-4 BMD) is -2.5 SD** or less
- •*: Fragility fracture is the fracture caused by slightly external force, due to low bone mass.
- •This study is only limited to fragility fracture of vertebral (4 th to 12th thoracic vertebrae) and femur, humerus, forearm occurred after age 50 and later.
- •**: Using BioClinica's center to analyze bone mineral density.
- •2) Although there is no gender limit, female patients should be postmenopausal for 3 or more years. When menopause is unknown, subjects should be 60 years old or older.
- •3) Outpatients who are able to walk.
- •4) Patients who can understand the informed consent form, participate in this study voluntarily, and have signed the inform consent by themselves or their legal representatives.
排除标准
- •Subjects meeting any of the following exclusion criteria will not to be included in this study.
- •(1) Patients having any of the following history of usage of bisphosphonate formulations
- •Patients who received oral bisphosphonate formulations once or more times within 2 months prior to screening,
- •Patient who recieved oral bisphosphonate fomulations for 4weeks or longer within 1 year prior to screening. For non-continuous oral administration preparation, the dosing interval will be considered as administration time. (eg, preparation for once a week, the one time of administration should be 1 week).
- •Patients who used oral bisphosphonate formulations once or more times for the purpose other than the treatment of osteoporosis.
- •Patients who were injected bisphosphonate formulations once or more times.
- •(2) Within 2 months prior to screening, patients who received following treatment of drugs which may affect bone metabolism (except for calcium preparations)
- •Active vitamin D3 preparations (including external medicine)
- •Vitamin K2 preparation
- •Calcitonin preparations
- •Selective estrogen receptor modulators
- •Sex hormone preparations (excluding vaginal tablets, creams etc)
- •Adrenocorticotropic hormone (excluding inhaler, nasal administrations, other external medicine and local injections)
- •GnRH-a preparations
- •Antiestrogen preparations
- •Cyclosporine
- •(3) Patients who used following drugs:
- •Parathyroid hormone preparation
- •Anti-RANKL antibody
- •Cathepsin K inhibitors
- •Strontium preparations
- •Anti-Sclerostin antibody
- •(4) Within 4 months prior to screening, patients who received treatment of other investigatory drugs (including placebo)
- •(5) Patients who are currently receiving thyroid hormone replacement therapy, and their TSH less than 0.1micro-U/mL within 3 months prior to obtaining their informed consent
- •(6) Patients with history of gastrectomy (2/3 and more), extensive small bowel resection etc.
- •(7) Patients with diseases causing decreased bone mass, other than primary osteoporosis
- •1) Secondary osteoporosis
- •I) Endocrine: gonadal dysfunction, hyperthyroidism, Cushing's syndrome
- •II) Nutrition: vitamin C deficiency, protein deficiency, vitamin A or vitamin D intoxication
- •III) Drugs: methotrexate (MTX), heparin
- •IV) Disuse: systemic (bedridden, paralyzed)
- •V) Congenital: osteogenesis imperfecta, Marfan syndrome etc
- •VI) Other: rheumatoid arthritis, poorly controlled diabetes (HbA1c: >= 9%)
- •2) Other diseases causing low bone mass
- •I)Various osteomalacia
- •II)Primary, secondary hyperparathyroidism
- •III)Bone metastasis of malignant tumors
- •IV)Multiple Myeloma
- •(8) Patients who have following condition can impact the DXA evaluation of bone mineral density of lumbar spine:
- •Patients with severe deformation or fracture of L1-4 vertebral body
- •Patients with severe degeneration or bone sclerosis image of L1-4 vertebral body
- •Patients with highly extrapyramidal calcified image, which overlaps with L1-4 vertebral body
- •Patients with other abnormalities which might affect examination of bone mineral density of the lumbar spine
- •(9) Patients with the sCr value exceeds the upper limit of the normal range of the center at screening
- •(10) Patients with adjusted sCr value exceeds 2.59 mmol/L (10.4 mg/dL) at screening or uCa/uCr value exceeds 0.4 at screening
- •(11) Patients having urinary tract calculi by B-mode ultrasonography examination at screening or history of urinary tract calculi
- •(12) Patients with severe liver disease such
研究者
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