EUCTR2008-002898-12-BE进行中（未招募）1 期
An open label, Aclasta, re-treatment of relapsed patients with Paget´s disease of bone who participated in the CZOL446K2304 and CZOL446K2305 Core Registration studies - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •- Patients must give written informed consent to participate in the study
- •- Male or female patients who were randomized to receive zoledronic acid in the CZOL446K2304 (previously referred to as CZOL446H2304) or CZOL446K2305 (previously referred to as CZOL446H2305) pivotal studies and met the definition of responder at the 6 month post-dose visit
- •- Confirmed relapse of Paget´s disease of the bone based on investigator´s assessment through one or more of the following: SAP that is above the ULN, bone scan consistent with relapse of Paget´s disease of bone, and/or worsening of clinical symptoms (e.g., bone pain or compression symptoms)
- •Are the trial subjects under 18? no
- •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
- •- A patient treated with Aclasta, who relapsed during the EOP and was treated with anti-resorptive bisphosphonate or calcitonin therapy within the past 12 months
- •- Hypersensitivity to any drug within the class of bisphosphonates
- •- Patients with a new diagnosis or active treatment for malignancy (other than basal cell or squamous cell skin cancer) less than or equal to 12 months prior to study entry
- •- Patients with suspected or proven metastases at time of re-treatment
- •- Patients who are unlikely to be able to complete the study or comply with the visit schedule and required assessments due to cancer, non-skeletal metastases or paraneoplastic syndrome or their ongoing/planned treatments
- •- Specific exceptions to the cancer exclusion (within 12 months prior to re-treatment). Patients may be included if: Basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy have been removed, ductal Carcinoma in-situ (DCIS) has been surgically removed, carcinoma in-situ (CIS) of the uterine cervix has been surgically removed
- •- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive urine test
- •- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
- •Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent
- •- Reliable contraception should be maintained throughout the study and for 60 days after study drug discontinuation
- •- Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml and estradiol <20 pg/ml or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks prior to visit 2. In the case of oophorectomy alone, classification of a woman as post-menopausal would occur when her reproductive status has been confirmed by follow up hormone level assessment
- •- Any disease or therapy which will interfere with the procedures or data collection of this trial
- •- Patients with active (symptomatic or asymptomatic) iritis, uveitis or episcleritis
- •- Calculated creatinine clearance <35 ml/min at screening visit
- •- Serum calcium level <2.07 mmol/L
- •- Active primary hyperparathyroidism, hyperthyroidism, hypoparathyroidism or hypothyroidism
- •No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients
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