A 3-year, multicenter, double-blind, randomized, placebo-controlled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis - 2301 E2

ovartis Pharma Services AG0 个研究点目标入组 0 人2008年7月15日

适应症Osteoporosis in postmenopausal women MedDRA version: 9.1 Level: LLT Classification code 10031282 Term: Osteoporosis

相关药物Aclasta 5 mg solution for infusion

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Osteoporosis in postmenopausal women
发起方: ovartis Pharma Services AG
状态: 进行中（未招募）
最后更新: 6年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2008年7月15日

结束日期

2013年4月11日

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

研究者

发起方

ovartis Pharma Services AG

入排标准

入选标准

•1\. Women who have completed Study CZOL446H2301E1 and received at least the 4th and 6th doses of zoledronic in Study CZOL446H2301E1according 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 CZOL446H2301E1(1000 to 1500 mg of elemental calcium or adequate dietary intake for patients who are intolerant to calcium and 400 to 1200 IU of vitamin D daily) for at least 3 months prior to entry into the extension CZOL446H2301E2\.
•5\. Patients must have DXA measurements of the hip performed at Visit 11 (Study 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) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) yes

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 iv 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 CZOL446H2301E1 but 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\.