NCT00431444已完成4 期
A Multi-center, Randomized, Double-blind, Double-dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg OD on Bone Turnover Markers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 110
- 试验地点
- 16
- 主要终点
- Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
研究概览
简要总结
This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
- •Cessation of menses for 18 months in women < 50 years of age
- •Cessation of menses for 12 months in women age 50 years or over
- •Documented bilateral oophorectomy at least 1 year previously
- •Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
- •Signed informed consent prior to initiation of any study procedure
排除标准
- •Prior treatment with i.v. bisphosphonates within the last 2 years
- •Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks*).
- •*NOTE: If used less than 8 weeks, the washout period is 6 months.
- •Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
- •Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
- •Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
- •Treatment with any investigational drug within 30 days prior to randomization
- •Any woman of child bearing potential
- •Patients with fractures occurring within three months prior to randomization
- •History of hypersensitivity to bisphosphonates
- •History of non-traumatic uveitis or iritis, within 2 years prior to study entry.
- •A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
- •Previous major solid organ transplant recipient or on a transplant waiting list
- •History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
- •Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months
- •Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial
- •Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization.
- •Calculated creatinine clearance < 30 mL/min
- •Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
- •Serum calcium > 2.75 mmol/L (11.0 mg/dL) or < 2.08 mmol/L (8.3 mg/dL) at screening
- •AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal
研究组 & 干预措施
Zoledronic Acid
Active Comparator
Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)
干预措施: Zoledronic acid (Drug)
Zoledronic Acid
Active Comparator
Zoledronic acid 5 mg (single i.v. infusion) + daily oral placebo for 6 months (zoledronic acid group)
干预措施: Placebo oral pills (Drug)
Raloxifene
Active Comparator
Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
干预措施: Raloxifene (Drug)
Raloxifene
Active Comparator
Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
干预措施: Placebo intravenous (i.v.) infusion (Drug)
结局指标
主要结局
Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
时间窗: Baseline and 6 months
The primary efficacy variable was the change from baseline in urine NTx (corrected by creatinine). The primary analysis time point was at 6 months of treatment. The results are reported as nanomoles (nM) of bone collagen equivalents (BCE) per millimole (mM) of urine creatinine.
次要结局
- Change From Baseline in Urine NTx at 2 Months(Baseline and 2 months)
- Change From Baseline in Urine NTx at 4 Months(Baseline and 4 months)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months(Baseline and 2 months)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months(Baseline and 4 months)
- Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months(Baseline and 6 months)
- Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire(Immediately after infusion procedure)
- Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire(Immediately after infusion procedure)
- Overall Patient Satisfaction Assessed by Satisfaction Questionnaire(Immediately after infusion procedure)
- Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens(At 6 month visit)
研究者
研究点 (16)
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