EUCTR2004-000485-13-HU进行中（未招募）不适用
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study ofOne-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Administered 2.5 mg or 5.0 mg Daily Risedronate,in Children = 4 to < 16 Years Old with Osteogenesis Imperfecta. - POISE
Procter & Gamble Ltd0 个研究点目标入组 124 人开始时间: 2006年7月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
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
- All
入选标准
- •To be enrolled in this study, a child must meet the following:
- •a) diagnosed with OI as based on a modified classification scale7,8 (Appendix 1)
- •b) aged 4 through 15 years (= 4 to < 16), inclusive
- •c) have an increased risk of fractures as defined by:
- •a history of at least 1 radiographically confirmed, non-traumatic or low impact
- •fracture, plus low BMD (Z-score = -1 at either total body or lumbar spine sites);
- •very low BMD (Z-score = -2.0 at either total body or lumbar spine sites) with or
- •without a history of fractures
- •d) have at least 2 evaluable lumbar spine vertebral bodies (L1-L4), namely without fracture or degenerative disease
- •e) if female, post-menarche and sexually active, must be willing to agree to use a reliable contraceptive measure for the duration of the study. Acceptable forms of contraception include oral, injected or implanted contraceptives, or intrauterine devices.
- •f) if female and post-menarche, must have a negative serum and urine pregnancy test at Screening
- •g) able and willing to participate in the study as evidenced by a parent/legal guardian signing a valid written informed consent and the patient signing an assent (if appropriate).
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a) body weight < 10 kg
- •b) history of cancer within the past 5 years
- •c) untreated rickets within 1 year prior to enrollment
- •d) history of clinically significant organic or psychiatric disease or findings on physical
- •examination, which in the opinion of the Investigator, would prevent the patient from
- •completing the study
- •e) documented history of an abnormal or allergic reaction to bisphosphonates
- •f) abuse of alcohol
- •g) abuse of prescription or illicit drugs
- •h) history of using any of the following medications, regardless of dose, for at least
- •1 month, within 3 months of enrollment:
- •anabolic agents
- •estrogen (except contraceptives)
- •progestogens (except contraceptives)
- •calcitriol, calcidiol, or alfacalcidol
- •calcitonin
- •fluoride (except dental health products)
- •glucocorticoids (does not include inhaled glucocorticoids)
- •growth hormones
- •parathyroid hormone (PTH)
- •strontium
- •i) history of using any bisphosphonates within 1 year of enrollment, except for a single dose of oral bisphosphonate, such as risedronate or alendronate
- •j) osteoporosis, secondary to diseases other than OI or drug therapies
- •k) clinically significant abnormal laboratory finding at Screening, as follows:
- •liver function test (LFT), either AST or ALT > 2 x ULN
- •thyroid stimulating hormone (TSH) and PTH outside of the normal reference range
- •Note: An iPTH level below the lower limit of the normal range may be associated
- •with calcium supplementation. Therefore, the Investigator and the Medical Monitor
- •will review the patient's personal data and medical history to confirm or refute that
- •the low iPTH level is associated with high calcium supplementation
- •serum 25(OH) vitamin D < 20 nmol/L (8 ng/mL)
- •serum creatinine > 106 µmol/L (1.2 mg/dL)
- •l) current use of anticonvulsant medication
- •m) current use of anticoagulant medication
- •n) participation in another clinical trial within 3 months of enrollment.
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