EUCTR2007-005383-27-DE进行中（未招募）不适用
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
适应症
相关药物
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 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 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) 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 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.
- •11. Active primary hyperparathyroidism.
- •12. Surgery to the thyroid or parathyroids resulting in partial or complete hypoparathyroidism.
- •13. Uncontrolled seizure disorders associated with falls.
- •14. Bilateral hip replacement or bilateral hip surgery with implantation of an appliance during the Study CZOL446H2301E1.
- •15. Patients with a new diagnosis or active treatment for cancer with the exception of treated non-melanoma skin cancer during the course of Study CZOL446H2301E1.
- •16. Multiple myeloma or Paget’s disease diagnosed or discovered during Study CZOL446H2301E1.
- •17. Active iritis or uveitis at the time of randomization.
- •18. History of diabetic nephropathy or retinopathy or uncontrolled diabetes (e.g. patients with a history of HbA1c > 10%).
- •19. A calculated creatinine clearance less than 30.0 mL/min (0.5 mL/sec) or urine dipstick greater than 2+ protein without evidence of contamination or bacteriuria at Visit 11 (final Study CZOL446H2301E1 study visit) or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2.
- •20. History of hypersensitivity to bisphosphonates or any serious adverse reaction to the study drug during Study CZOL446H2301E1.
- •21. Use of other investigational drugs within 3 months prior to randomization in Study CZOL446H2301E2.
- •22. Any medical or psychiatric condition which, in the Investigator’s opinion, would preclude the participant from adhering to the Protocol or completing the trial per protocol.
- •23. Patients with a decrease in bone mineral density at the total hip of greater than 10% from basel
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