EUCTR2004-000512-17-FI进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-controlled Study to Evaluate AMG 162 in theTreatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy forNon-metastatic Prostate Cancer
适应症
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
- 1,468
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
- Male
入选标准
- •- Patients = 70 years of age, with histologically confirmed prostate cancer
- •- Adult patients, < 70 years of age, with histologically confirmed prostate cancer and a history of osteoporotic fracture, or BMD t-score at the lumbar spine, total hip, or femoral neck < -1.0 (BMD using the male normative database)
- •- Have undergone bilateral orchiectomy or initiated ADT with GnRH agonists and
- •is expected to continue on with ADT for at least 12 months
- •- ECOG score 0, 1, or 2
- •- Before any study-specific procedure, provide written informed consent
- •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
- •- Evidence of distant metastases
- •- Concurrent systemic anti-neoplastic therapy, other than ADT and/or antiandrogen
- •- Diagnosis of any secondary non- prostate malignancy within 5 years of randomization, except for adequately treated basal cell or squamous cell skin
- •- PSA > 5 ng/mL after being on ADT >1 month
- •- BMD t-score < -4.0 at lumbar spine, total hip, or femoral neck
- •- Height, weight, and girth which may preclude accurate DXA measurements
- •- Less than 2 evaluable lumbar vertebrae (L1-L4) for DXA measurement
- •- Current administration of oral bisphosphonates, or previous use as follows:
- •Greater than or equal to 3 years continuously
- •Greater than 3 months but less than 3 years (eligible only if patient has a 1 year washout prior to randomization)
- •- Current administration of IV bisphosphonates, fluoride, strontium ranelate, or gallium nitrate, within the past 5 years
- •- Administration of any of the following treatments within the past 6 weeks:
- •PTH or PTH derivatives
- •Anabolic steroids or testosterone
- •Glucocorticoids (> 10 mg prednisone/day for more than 10 days)
- •Selective estrogen receptor modulators (SERMS)
- •Calcitonin
- •Calcitriol
- •- Concurrent chronic corticosteroid therapy or pulse corticosteroid therapy (topical, inhaled, or nasal steroids are allowed)
- •- Prior administration of OPG construct (i.e. AMGN-0007, Fc-OPG), or AMG 162
- •- Concurrent use of PC SPES
- •- 25-hydroxyvitamin D deficiency (< 12 ng/mL)
- •- Serum calcium or albumin-adjusted serum calcium levels < 2.0 mmol/L (8.0 mg/dL), or =2.9 mmol/L (11.5 mg/dL)
- •- Serum creatinine > 177 µmol/L (>2.0 mg/dL)
- •- Hepatic insufficiency [AST > 2.5 x upper limit of normal (ULN), ALT > 2.5 x ULN, or total bilirubin > 1.5 x ULN]
- •- iPTH > 1.5 x ULN
- •- ANC < 1.5 x 109/L; platelets < 100 x 109/L; or hemoglobin < 6.2 mmol/L (10.0
- •- Evidence of any of the following conditions per subject self report or chart review:
- •a) Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if the TSH is within the normal range)
- •b) Paget’s disease, Cushing’s disease, hyperprolactinemia, or chronic liver disease
- •c) Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization
- •d) Major surgery, or significant traumatic injury occurring within 4 weeks before randomization
- •e) Known HIV, HCV, or chronic Hepatitis B infection
- •- Organic or psychiatric disorder which, in the opinion of the investigator may prevent the subject from completing the study or interfere with the interpretation of the study results
- •- Any kind of disorder that compromises his ability to give written informed consent and/or to comply with study procedures
- •- Is currently enrolled in the active treatment phase of a study investigating an unapproved product or device, or has been treated within the last 30 days with an unapproved product or device. Subjects in the observational phase of clinical studies ( eg, to collect survival data) are allowed
- •- Self-reported drug or alcohol abuse within the previous 24 weeks before study enrollment
- •- Known sensitivity to any of the products to be administered during this study.
研究者
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