A Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study of Acetaminophen or Fluvastatin Compared to Placebo on the Transient Post-Dose Symptoms (PDS) Following an i.v. Infusion of a Single Dose of Zoledronic Acid 5mg, in Post-menopausal Women With Low Bone Mass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 793
- 试验地点
- 1
- 主要终点
- Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
研究概览
简要总结
This study will evaluate the efficacy of acetaminophen or fluvastatin in reducing the rate of occurrence and the severity of post dose symptoms that may occur during the 3 day period following a zoledronic acid infusion in post menopausal women with low bone mass.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
- •Women who are clinically indicated for treatment with Bisphosphonates for osteopenia or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score less than or equal to 1.5
排除标准
- •Any prior treatment with intravenous Bisphosphonates
- •Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
- •Patients who are taking, and are unwilling or unable to stop taking, certain medications
- •Patients who require anticoagulant therapy
- •Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
- •Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
- •Protocol specific laboratory values that fall out of range for this study
- •Ongoing infection (oral body temperature greater than or equal to 37.5C (99.5°F),chronic febrile disease or fever of unknown origin at screening or randomization
- •Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
- •History of iritis, uveitis or chronic conjunctivitis
- •History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
- •Partial or total removal of parathyroid or thyroid gland
- •History of malignancy of any organ system, treated or untreated, within the past 1 year whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
- •Treatment with an investigational drug within the previous 30 days of screening
- •Patients with any medical or psychiatric condition which, in the opinion of the Principal Investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol, or any patient who the Principal Investigator thinks should not participate in the study for any reason, including current drug or alcohol abuse
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Acetaminophen
2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
干预措施: Acetaminophen (Drug)
Fluvastatin
2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
干预措施: Fluvastatin (Drug)
Placebo
2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature or Use of Rescue Medication.
时间窗: 0 - 3 days
Clinically significant increase in oral body temperature or used rescue medication ibuprofen \>= 1 time during the 3-day period after i.v. infusion of zoledronic acid 5 mg. A clinically significant increase in body temperature was defined as an increase of at least 1 degree Celsius from baseline and a mean oral body temperature reading of at least 38.5 degrees Celsius occurring at least once during the 3-day treatment period.
次要结局
- Proportion of Patients With a Clinically Significant Increase in Oral Body Temperature.(0 - 3 days)
- Proportion of Patients Who Used Rescue Medication.(0 - 3 days)
- Number of Rescue Medication Tablets Taken(0 - 3 days)
- Time to First Rescue Medication After Infusion of Zoledronic Acid 5 mg.(0 - 3 days)
- Proportion of Patients With a Major Increase (Worsening) in Severity of Questionnaire Symptoms.(0 - 3 days)
- Proportion of Patients Reporting Severe Questionnaire Symptoms.(0 - 3 days)
- Change From Baseline in Visual Analog Scale (VAS) Measurement of Symptom Severity(0 - 3 days)