EUCTR2012-001821-28-PL进行中（未招募）不适用
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
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
- 620
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
- •- Subject or subject’s legally acceptable representative has provided informed consent prior to any study specific procedure(s)
- •- Ambulatory postmenopausal women. Ambulatory is defined as women who are able to walk, not bedridden; postmenopause is defined as no vaginal bleeding or spotting for at least 12 months prior to screening.
- •- Age 55 years or older
- •- Received oral bisphosphonate therapy for OP for at least 2 years immediately prior to screening visit
- •- Screening BMD (g/cm2) values at the lumbar spine, total hip or femoral neck; values of equal to or less than those listed in the protocol. Eligibility will be determined by a local reading of the DXAs at the investigator site. At least 2 lumbar vertebrae and one hip must be evaluable by DXA at the screening visit.
- •- Serum CTX value of = 0.5 ng/mL at the screening visit as determined by central laboratory
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 440
排除标准
- •- Height, weight or girth which may preclude accurate DXA measurements
- •- Received other OP treatment or bone active treatment with the following guidelines
- •administration of denosumab or zoledronic acid at any time
- •administration of the following within the last 5 years
- •o IV bisphosphonate other than zoledronic acid
- •o fluoride or strontium at doses approved for OP
- •o PTH or PTH derivatives within the last year
- •Abnormalities of the following per central laboratory reference ranges:
- •vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be allowed and subjects may be re-screened
- •hypercalcemia
- •elevated transaminases = 2.0 x upper limits of normal (ULN)
- •Administration of any of the following treatment within 3 months of screening:
- •any selective estrogen receptor modulator (estrogen agonist antagonist)
- •anabolic steroids or testosterone
- •glucocorticosteroids (= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of = 50 mg)
- •systemic hormone replacement therapy (HRT) (subjects stable on HRT for more than 3 months prior is permitted)
- •calcitonin
- •other bone active drugs including anti-convulsants (except
- •benzodiazepines) and heparin
- •cathepsin K inhibitor
- •anti-sclerostin antibody
- •chronic systemic ketoconazole, androgens, adrenocorticotrophic
- •hormone, cinacalcet, aluminum, lithium, protease inhibitors,
- •gonadotropin- releasing hormone agonists
- •- Evidence of history of any of the following:
- •hyperthyroidism (stable on antithyroid therapy is allowed)
- •hypothyroidism (stable on thyroid replacement therapy is allowed)
- •hypo- or hyperparathyroidism
- •hypo- or hypercalcemia based on the central laboratory reference ranges
- •known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
- •osteomalacia (chart review)
- •osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease
- •recent tooth extraction (within 6 months of screening visit)
- •Paget disease of bone (subject report or chart review)
- •other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
- •History of any solid organ or bone marrow transplant
- •- Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
- •- Contraindicated or poorly tolerant of denosumab therapy; contraindications include
- •hypocalcemia
- •hypersensitivity to drug or any component of the drug
- •- Contraindicated or poorly tolerant of zoledronic acid therapy;
- •contraindications include the following:
- •hypocalcemia
- •subjects with creatinine clearance of <35 mL/min and in those with evidence of acute renal impairment (calculated using Cockcroft Gault equation)
- •hypersensitivity to any component of zoledronic acid solution
- •- Known intolerance to calcium or vitamin D supplements
- •- For women of child bearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication
- •- Self-reported alcohol or drug abuse within 12 months prior to screening
- •- Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigation
研究者
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