EUCTR2008-005991-28-ES进行中（未招募）1 期
A Randomized, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women with Low Bone Mineral Density / Estudio de fase 2 aleatorizado, controlado con placebo, de dosis múltiple para determinar la eficacia, la seguridad y la tolerabilidad de AMG 785 en el tratamiento de mujeres posmenopáusicas con baja densidad mineral ósea
适应症
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
- 419
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
- •To be eligible for enrollment subjects must meet the following criteria:
- •- Ambulatory, postmenopausal women (based on medical history) aged > or = 55 to < or = 85. Postmenopausal will be defined as no vaginal bleeding or spotting for at least one year. If there is uncertainty regarding menopausal status:
- •- Women 60 years of age and older will be considered postmenopausal
- •- Women 55-59 must have confirmation of serum FSH > or = 50 mIU/ml and serum estradiol < or = 20 pg/mL at screening
- •- Low BMD measured by Dual energy X-ray Absorptiometry (DXA) and assessed by the central imaging vendor (refer to table below for eligible BMD values).
- •- Subjects must have at least two evaluable vertebrae in the L1-L4 region, and at least one evaluable hip.
- •- Subjects must not have a BMD value at any anatomical site (lumbar spine, total hip and femoral neck) that is below the lower limit specified for that site.
- •- Scans will be done in duplicate and the mean of the scans from at least one anatomical site (lumbar spine, total hip or femoral neck) must meet the BMD values defined in table below.
- •Eligible BMD values; Lunar (g/cm2); Hologic (g/cm2)
- •Lumbar Spine (a); < or =0.940 and > or = 0.760; < or= 0.827and > or = 0.662
- •Total Hip (b); < or= 0.756 and > or =0.567; < or= 0.698 and > or = 0.515
- •Femoral Neck (b); < or= 0.760 and > or = 0.551; < or= 0.618 and > or =0.438
- •(a) Values correspond to T-scores between -2.0 and -3.5 as determined by the manufacturer
- •(b) Values correspond to T-scores between -2.0 and -3.5 Based on data for Caucasian women from the National Health and Nutritional Examination Survey (NHANES) 1998
- •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 criteria are not eligible for participation in the study:
- •- History of vertebral fracture or fragility fracture (a fracture resulting from no or minor trauma, ie fall from standing height or less) of the wrist, humerus, hip or pelvis after age 50.
- •- History of metabolic or bone disease that may interfere with the interpretation of the results, such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
- •- Vitamin D deficiency (defined as 25 (OH) vitamin D levels < 20 ng/mL as determined by the central laboratory. Vitamin D repletion will be permitted and subjects may be re-screened once.
- •- Evidence of any of the following:
- •- Untreated hyper- or hypothyroidism (TSH out of normal range as determined by the central laboratory).
- •- Current hyper- or hypoparathyroidism (PTH outside the normal range as determined by the central lab).
- •- Elevated transaminases as determined by the central laboratory.
- •a) Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase [SGOT]) > or = 2.0 x upper limits of normal.
- •b) Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) > or = 2.0 x upper limits of normal.
- •- Significantly impaired renal function as determined by a derived creatinine clearance of less than or equal 30 mL/min using the Modification of Diet in Renal Disease equation, calculated by the central laboratory.
- •- Current hyper- or hypocalcemia as determined by the central laboratory analysis of albumin adjusted serum calcium.
- •- History of spinal stenosis.
- •- History of facial nerve paralysis.
- •- 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.
- •- History of solid organ or bone marrow transplants.
- •- Use of the following agents affecting bone metabolism:
- •- Intravenous bisphosphonates at any time in the past.
- •- Fluoride (for osteoporosis) within the past 24 months.
- •- Denosumab at any time in the past.
- •- Bisphosphonates, parathyroid hormone or strontium within the past 12 months.
- •- Calcitonin, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable) or tibolone within the past 3 months.
- •- Systemic glucocorticosteroids (> or = 5 mg prednisone equivalent per day for more than 10 days) within the past 3 months.
- •- Contraindicated or intolerant of ALN therapy; contraindications and potential signs of intolerance for ALN therapy include:
- •- Abnormalities of the esophagus and other factors which delay esophageal emptying such as stricture or achalasia.
- •- Inability to stand or sit upright for at least 30 minutes.
- •- Hypersensitivity to ALN or any component of the ALN product.
- •- Active gastric or duodenal ulcer; history of significant gastrointestinal bleed requiring hospitalization or transfusion, or dyspepsia or gastroesophageal reflux disease that is uncontrolled by medication.
- •- Contraindicated or intolerant of TPTD therapy; contraindications for TPTD therapy include:
- •- Hypersensitivity to teriparatide or to any of its excipients.
- •- Unexplained elevations of alkaline phosphatase.
- •- Prior external beam
研究者
相似试验
进行中（未招募）
1 期
Phase 2 Study of AMG 785 in Postmenopausal Women With Low Bone Mineral DensityPostmenopausal osteoporosisEUCTR2008-005991-28-ATAmgen Inc400
进行中（未招募）
不适用
Phase 2 Study of AMG 785 in Postmenopausal Women With Low Bone Mineral DensityMedDRA version: 14.1Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersPostmenopausal osteoporosisEUCTR2008-005991-28-BEAmgen Inc400
进行中（未招募）
不适用
Phase 2 Study of AMG 785 in Postmenopausal Women With Low Bone Mineral DensityPostmenopausal osteoporosisEUCTR2008-005991-28-DKAmgen Inc400
已完成
1 期
A clinical study to determine the safety of Spironolactone 5% topical cream in Healthy adult male subjects.CTRI/2018/02/012109Alkem Laboratories Ltd
进行中（未招募）
1 期
A placebo-controlled, multiple dose, phase IIb, dose guiding trial to explore safety and tolerability of four weeks treatment with sulthiame in patients with moderate to severe obstructive sleep apneaModerate to severe obstructive sleep apneaMedDRA version: 20.0Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndromeSystem Organ Class: 100000004855EUCTR2017-004767-13-SEDesitin Arzneimittel GmbH68