EUCTR2010-024393-19-BE进行中（未招募）1 期
A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen, Inc.
- 入组人数
- 776
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
- All
入选标准
- •- Glucocorticoid-initiating subpopulation:
- •Men and women = 18 years of age who have initiated
- •prednisone = 7.5 mg daily or its equivalent within 3 months prior to screening and are expected to be treated with oral glucocorticoids for a total of at least 6 months
- •- Glucocorticoid-continuing subpopulation:
- •Men and women = 18 years of age who are taking
- •prednisone = 7.5 mg daily or its equivalent for = 3 months preceding screening and are expected to be treated with oral glucocorticoids for a total of at least 6 months.
- •- Glucocorticoid-continuing subjects who are = 50 years of age will be required to have a BMD value equivalent to a T-score = -2.0 at the lumbar spine, total hip, or femoral neck; or a BMD value equivalent to a T-score = -1.0 at the lumbar spine, total hip, or femoral neck and with a
- •history of osteoporotic fracture.
- •- Men and women < 50 years old at the time of screening in both
- •glucocorticoid-continuing and glucocorticoid-initiating subpopulations, will be required to have a history of osteoporotic fracture.
- •- Ambulatory
- •- At least two lumbar vertebrae from L1 through L4 and one hip must be evaluable by DXA (duplicate scans required)
- •- Subject or subject’s legally acceptable representative has provided informed consent prior to any study specific procedures.
- •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 504
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 272
排除标准
- •Received other OP treatment or bone active treatment with the following guidelines
- •Oral bisphosphonate use
- •- >3 months cumulatively in the past 2 years
- •- >1 month in the past yea
- •Any use during the 3-month period prior to screening
- •Administration of intravenous bisphosphonate, fluoride or strontium for OP within the last 5 years
- •Parathyroid hormone (PTH) or PTH derivatives within the last year
- •Denosumab for OP at any time in the past
- •Administration of any of the following treatment within 3 months of screening:
- •Any selective estrogen receptor modulator (SERM) (estrogen agonist/antagonist)
- •Anabolic steroids or testosterone
- •Systemic hormone replacement therapy
- •Calcitonin
- •Other bone active drugs including anti-convulsants (except benzodiazepines) and heparin
- •Chronic systemic ketoconazole, androgens, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin-releasing hormone agonists
- •Administration of any of the following biologic agents within 4 weeks prior to screening
- •Anti alpha 4 integrin antibody (eg, natalizumab)
- •Anti CD4/CD8 T-cells (eg, alefacept)
- •Anti IL-12/IL-23 (eg, ustekinumab)
- •CTLA4 inhibitor (eg, abatacept)
- •IL1 receptor antagonist (eg, anakinra)
- •IL6 inhibitor (eg, tocilizumab)
- •Monoclonal antibody to CD20 (eg, rituximab)
- •TNF antagonist (eg, adalimumab, certolizumab, golimumab, etanercept, infliximab)
- •Administering >1 biologic agent for the treatment of underlying inflammatory disease
- •Subject has an active infection or history of infections as follows:
- •any active infection for which systemic anti-infectives were used within 4 weeks prior to screening
- •a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening
- •recurrent or chronic infections or other active infection
- •Evidence of any of the following
- •History of hyperthyroidism(stable on antithyroid therapy is allowed)
- •History of hypothyroidism(stable on thyroid replacement therapy is allowed)
- •History of hypo- or hyperparathyroidism
- •History of Addison disease
- •History of osteomalacia
- •History of osteonecrosis of the jaw
- •History of recent tooth extraction or other dental surgery within the prior 6 months
- •Invasive dental work planned in the next 2 years
- •History of Paget’s disease of bone
- •Other bone diseases which affect bone metabolism
- •Abnormalities of the following per central laboratory reference ranges
- •Vitamin D deficiency (25[OH] vitamin D level <20 ng/mL [<49.9 nmol/L])
- •Hypercalcemia
- •Elevated transaminases =2.0 x upper limit of normal (ULN)
- •Elevated total bilirubin (TBL) >1.5 x ULN
- •History of any solid organ or bone marrow transplant
- •Contraindicated to, or poorly tolerant of, denosumab therapy. Contraindications include:
- •Hypocalcemia
- •Hypersensitivity to drug or any component of the drug
- •Contraindicated to, or poorly tolerant of, risedronate therapy. Contraindications include:
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