EUCTR2004-001666-40-BE进行中（未招募）1 期
An international, multicenter, randomized, open-label, safety andefficacy trial of intravenous zoledronic acid administered eitheronce or twice yearly in children with severe osteogenesisimperfecta, a 1-year extension to CZOL446H2202 - 2202E
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
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
- •Children, male or female, between 1 year and 17 years of age at visit 1 of the extension, all inclusive, who have completed 1 year treatment of zoledronic acid or pamidronate in CZOL446H2202 trial.
- •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
- •Any disease or planned therapy which will interfere with the procedures or data collection of this trial.
- •Any disease or abnormality that would prevent accurate bone-mineral density measurements of the lumbar spine (e.g., intra-abdominal calcification that may prohibit accurate data collection/interpretation; severe scoliosis, kyphosis, or metal implants, etc.)
- •Any surgical bone-lengthening procedure, e.g. Ilizarov procedure planned/scheduled to occur during the trial.
- •Female patients of child-bearing potential are eligible only if they are: not pregnant (serum ß-hCG pregnancy-test negative)/non-lactating; are sexually abstinent or are surgically sterile (tubal ligation or hysterectomy): and if sexually active, must be practicing a medically acceptable form of birth control, defined as the use of an IUD, a barrier method with spermicide, condoms, subdermal implant or oral contraceptives. Females of child-bearing potential who are sexually active must agree to continue to practice their birth control during the trial and at least 1 year after completing the trial and must consent to a pregnancy test prior to every dose administration.
- •Renal abnormality (please see section 7.5.1): defined as a serum-creatinine value above the upper limit of normal (age- and sex-matched) or a urine dipstick greater than 2 + protein.
- •Hypocalcemia: any value (age-matched) below the normal range.
- •History or evidence of an intestinal malabsorption syndrome.
- •Patients with a significant drug-related adverse event in the original protocol.
- •Patients who discontinued treatment in the original protocol ZOL446H2202.
研究者
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