EUCTR2007-005383-27-IT进行中（未招募）不适用
A 3-year, multicenter, double-blind, randomized, placebocontrolled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
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
- Female
入选标准
- •1. Women who completed Study CZOL446H2301E1 and have received at least the received at least the 4th and 6th doses of zoledronic acid in Study CZOL446H2301E1 according to the guidelines and instructions provided. 2. Signed written informed consent to participate in the Study CZOL446H2301E2 3. Patients must be considered ambulatory. Patients can be included who are ambulatory with an assistive device (cane, walker, etc). 4. Patients must have been taking the dosage of calcium and vitamin D required in Study CZOL446H2301E1 (1000 to 1500 mg of elemental calcium and 400 to 1200 IU of vitamin D daily) for at least 3 months prior to entry into the CZOL446H2301E2. 5. Patients must have DXA measurements of the hip performed at Visit 11 (CZOL446H2301E1 final study visit).
- •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
- •1. Patients who demonstrated a major protocol violation in Study CZOL446H2301E1 or patients for whom the investigator feels participation in Study CZOL446H2301E2 is not appropriate. 2. Any prior use of i.v. bisphosphonate other than the study drug during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2. 3. Any use of oral bisphosphonates for more than 1 month total during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2. 4. Any prior use of PTH for more than 1 month during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1but prior to randomization in Study CZOL446H2301E2. 5. Use of systemic corticosteroids (oral or i.v.) at an average dose of greater than or equal to 7.5 mg per day of oral prednisone or equivalent for a period of three months just prior to randomization into Study CZOL446H2301E2. Note: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary. 6. Any use of anabolic steroids or growth hormone for more than 3 months just prior to randomization into Study CZOL446H2301E2. 7. Any prior use of strontium (all formulations). 8. Any use of sodium fluoride for osteoporosis during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2. 9. Serum calcium less than 8 mg/dL (2.0 mmol/L) at Visit 11 in Study CZOL446H2301E1 or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2. 10. Serum calcium greater than 11.0 mg/dL (2.75 mmol/L) at Visit 11 in Study CZOL446H2301E1 or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2.
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