NCT00936897已完成3 期
A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 833
- 主要终点
- Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
研究概览
简要总结
This is a multi-center, randomized, open-label, parallel group, study being conducted in the United States and in Europe in postmenopausal women. Approximately 800 subjects will be randomized across about 65 sites in a 1:1 ratio to either denosumab 60mg SC Q6M, or ibandronate 150mg PO QM.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, postmenopausal women (based on medical history) 55 years or older at screening
- •Postmenopause will be defined as no vaginal bleeding or spotting for at least 12 months
- •If the subject is 55 - 59 years old and there is uncertainty regarding menopausal status, confirmation of serum FSH (>= 50 mIU/mL) and serum estradiol (<= 20 pg/mL) must be obtained
- •If the subject is 60 years or older, evaluation of FSH and estradiol levels is not needed to confirm menopausal status
- •Have received their first prescription of daily or weekly bisphosphonate therapy at least 1 month prior to screening
- •May have received
- •raloxifene, calcitonin, prior to initiation of daily orweekly bisphosphonate therapy.
- •up to 3 doses of monthly bisphosphonate prior to initiation of daily or weekly bisphosphonate therapy
- •calcium, and vitamin D
- •Hormone replacement therapy (e.g. estrogen use for mitigation of menopausal symptoms)
- •Subject has:
- •Stopped daily or weekly bisphosphonate therapy (is denoted as non-persistent) at least one month before the screening visit, or
- •Demonstrated low adherence to therapy assessed by a score of less than 6 on the OS-MMAS
- •Screening BMD (g/cm2) values, at the lumbar spine OR total hip, that occur within the following ranges, based on the particular scanner that is used:
- •GE Lunar Lumbar spine 0.700 < or = BMD < and = 0.940 Total hip 0.504 < or = BMD < or = 0.756
- •Hologic Lumbar spine 0.607 < or = BMD < or = 0.827 Total hip 0.454 < or = BMD < or = 0.698 Both the initial and the repeat DXA scan of the lumbar spine OR the total hip must meet the above eligibility criteria.
- •At least 2 lumbar vertebrae must be evaluable by DXA.
- •At least one hip must be evaluable by DXA (eg, no history of either bilateral hip replacement or pins in both hips)
- •Provide signed informed consent before any study-specific procedures are conducted
排除标准
- •Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
- •Current or prior use of medications prescribed for osteoporosis treatment other than oral daily or weekly bisphosphonate
- •Contraindicated to receive oral ibandronate 150mg PO QM, including
- •Hypersensitivity to ibandronate 150mg PO QM or other constituents of ibandronate 150mg PO QM tablets
- •Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia
- •Inability to stand or sit upright for at least 60 minutes
- •Administration of any of the following treatments within 3 months of screening
- •Anabolic steroids or testosterone
- •Glucocorticosteroids (>= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of >= 50 mg)
- •Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)] - Repletion will be allowed and subjects may be re-screened
- •Evidence of any of the following per subject report, chart review or central laboratory result:
- •Significantly impaired renal function as determined by estimated Glomerular Filtration Rate less that 30mL/min/1.73 m2 determined by the central laboratory
- •Current hypo- or hypercalcemia based on the central laboratory reference ranges
- •Active gastric or duodenal ulcer; or any history of significant gastrointestinal bleed requiring hospitalization or transfusion
- •Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
- •Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years
- •Any metabolic bone disease or secondary cause of bone loss that is not controlled and may interfere with the interpretation of the findings
- •Previous participation in clinical trials with denosumab 60mg SC Q6M (regardless of treatment)
- •Received any solid organ or bone marrow transplant
- •Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
- •Known sensitivity to mammalian cell derived drug products
- •Known intolerance to calcium supplements
- •Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s)
- •Any physical or psychiatric disorder which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results
- •Evidence of alcohol or substance-abuse within the last 12 months which the investigator believes would interfere with understanding or completing the study
研究组 & 干预措施
Ibandronate
Active Comparator
Ibandronate 150mg PO QM (tablet)
干预措施: Ibandronate (Drug)
Denosumab
Experimental
denosumab 60mg Subcutaneous Q6M (pre-filled syringe)
干预措施: Denosumab (Drug)
结局指标
主要结局
Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
时间窗: Baseline to month 12
次要结局
- Serum Type-1 C-Telopeptide Percent Change From Baseline at Month 1(Baseline to month 1)
- Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12(Baseline to Month 12)
- Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12(Baseline to month 12)
研究者
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