EUCTR2009-010726-19-ES进行中（未招募）不适用
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./ Estudio abierto aleatorizado para evaluar la seguridad y eficacia de denosumab e ibandronato en mujeres posmenopáusicas infratratadas con bisfosfonatos diarios o semanales.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 800
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
- •Subjects will meet all of the following inclusion criteria prior to enrollment:
- •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 - 60 years old and there is uncertainty regarding menopausal status, confirmation of serum FSH (> or = 50 mIU/mL) and serum estradiol (< or = 20 pg/mL) must be obtained
- •- If the subject is greater than 60 years old, 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 6 months but no more than 18 months prior to screening.
- •May have received:
- •-- raloxifene, calcitonin, prior to initiation of bisphosphonate therapy.
- •-- calcium, and vitamin D.
- •-- Hormone replacement therapy (e.g. estrogen use for mitigation of menopausal symptoms).
- •Subject has:
- •-- Stopped 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:
- •Lumbar spine: GE Lunar: 0.700 < or = BMD < or = 0.940; Hologic: 0.607< or = BMD < or = 0.827.
- •Total hip: GE Lunar: 0.504 < or = BMD < or = 0.756; Hologic: 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.
- •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
- •Subjects meeting any of the following c.riteria are not eligible for participation in the study:
- •Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
- •Current use of medications prescribed for osteoporosis treatment other than oral daily or weekly bisphosphonate.
- •Contraindicated to receive oral ibandronate 150 mg PO QM, including.
- •-- Hypersensitivity to ibandronate 150 mg PO QM or other constituents of ibandronate 150 mg 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:
- •-- Tibolone.
- •-- Anabolic steroids or testosterone.
- •-- Glucocorticosteroids (> or = 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of > or = 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.
- •-- 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 60 mg 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.
研究者
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