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临床试验/NCT00950950
NCT00950950已完成1 期

A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Effect of AMG 785 on Parameters of Bone Quality of the Forearm Using pQCT in Postmenopausal Women With Low Bone Mineral Density

Amgen0 个研究点目标入组 24 人开始时间: 2009年8月18日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Amgen
入组人数
24
主要终点
Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the effect of romosozumab on parameters of bone quality of the forearm using peripheral quantitative computed tomography (pQCT) following multiple subcutaneous dose administrations of romosozumab in postmenopausal women with low bone mass.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
55 Years 至 80 Years（Adult, Older Adult）
性别
Female
接受健康志愿者
是

入选标准

  • •Healthy females between 55 to 80 years of age
  • •Postmenopausal females (based on medical history) defined as 12 continuous months of spontaneous amenorrhea
  • •Women 60 years of age and older will be considered postmenopausal
  • •Women 55-59 must have a serum follicle-stimulating hormone result > 40 mIU/mL and serum estradiol ≤ 20 pg/mL
  • •Low bone mineral density (BMD), defined as a BMD T-score between -1.0 and -2.5 at the lumbar spine (L1-L4) and/or femoral neck
  • •Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
  • •25-hydroxyvitamin D ≥ 20 ng/mL at screening
  • •Willing and able to take ≥ 500 mg calcium and ≥ 400 IU (but ≤ 1,000 IU) vitamin D daily

排除标准

  • •Osteoporosis, defined as a BMD T-score ≤ -2.5 at the lumbar spine or femoral neck
  • •History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis
  • •Diagnosed with any condition that will affect bone metabolism
  • •Subjects with fewer than 2 evaluable vertebrae; metal in forearms bilaterally that would not allow for at least one evaluable forearm
  • •Administration of the following medications within 6 months before study drug administration. This includes all routes of administration, for example intranasal and topical skin patches, unless otherwise noted:
  • •Hormone replacement therapy [(eg, estrogen, estrogen-like compounds such as raloxifene). Infrequent use of estrogen vaginal creams (< 3 times per week) is allowed.]
  • •Calcitonin
  • •Parathyroid hormone (or any derivative)
  • •Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed)
  • •Anabolic steroids
  • •Calcitriol, and available analogues
  • •Administration of daily, weekly, or monthly bisphosphonates (BP) unless meeting the following criteria:
  • •< 2 weeks of BP use requires a 2-month washout period
  • •2 weeks to 3 months of BP use requires a 9-month washout period
  • •3 to 6 months of BP use requires a 1-year washout period
  • •> 6 months of BP use requires a 3-year washout period;
  • •Greatly differing levels of physical activity or constant levels of intense physical exercise during the 6 months before study drug administration
  • •Known sensitivity to mammalian-derived drug preparations
  • •Known to be hepatitis B surface antigen, hepatitis C virus or human Immunodeficiency virus (HIV) positive or a known diagnosis of acquired immunodeficiency syndrome (AIDS)
  • •Any organic or psychiatric disorder, which, in the opinion of the investigator, poses a risk to subject safety and may prevent the subject from completing the study or interfere with the interpretation of the study results
  • •Unavailable for follow-up assessment or any concerns for subject's compliance with the protocol procedures
  • •Any other condition that might reduce the chance of obtaining data required by the protocol or that might compromise the ability to give truly informed consent
  • •History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the Investigator or Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • •Clinically significant abnormality during the screening physical examination, electrocardiogram (ECG) or laboratory evaluation
  • •Participation in another clinical study within 4 weeks of screening or within 5 times the half-life of the investigational agent in the other clinical study, if known
  • •Has donated or lost 400 mL or more of blood or plasma within 8 weeks of study drug administration
  • •Previous AMG 785 exposure

研究组 & 干预措施

Placebo

Placebo Comparator

Participants were randomized to receive matching placebo administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.

干预措施: Placebo (Drug)

Romosozumab

Experimental

Participants were randomized to receive 3 mg/kg romosozumab administered by subcutaneous injection once every 4 weeks (Q4W) for 3 months.

干预措施: Romosozumab (Drug)

结局指标

主要结局

Percent Change From Baseline in Polar Cross-sectional Moment of Inertia at the Distal Radius

时间窗: Baseline and days 29, 57, 85, 127, and 169

The polar moment of inertia is a geometric measurement used to predict bone quality, specifically the ability to resist torsion (twisting), and is highly correlated with fracture load at the distal radius. The polar cross-sectional moment of inertia was assessed using peripheral quantitative computed tomography (pQCT), a 3-dimensional imaging technology which can be used for volumetric analysis of appendicular skeletal sites such as the arms and the legs. The distal slice was acquired at 20% of the length of the ulna proximal to the radial endplate. Scans were analyzed by a central reader.

次要结局

  • Percent Change From Baseline in Cortical Bone Area at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Total Bone Area at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Total Bone Mineral Content at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Periosteal Circumference at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Cortical Thickness at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Polar Section Modulus at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Polar Strength Strain Index at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Axial Moment of Inertia at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Total Bone Mineral Density at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Cortical Bone Mineral Content at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Cortical Bone Mineral Density at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Endocortical Circumference at the Distal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Trabecular Bone Mineral Content at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Trabecular Bone Mineral Density at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Polar Strength Strain Index at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Bone Mineral Density at the One-third Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Bone Mineral Density at the Total Wrist(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Bone Mineral Density at the Total Lumbar Spine(Baseline and days 85 and 169)
  • Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)(Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169)
  • Percent Change From Baseline in Serum C-Telopeptide (sCTX)(Baseline and days 4, 15, 29, 57, 62, 71, 85, 99, 127, and 169)
  • Time to Maximum Serum Concentration (Tmax) of Romosozumab(First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)
  • Percent Change From Baseline in Total Bone Area at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Total Bone Mineral Content at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Total Bone Mineral Density at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Percent Change From Baseline in Trabecular Bone Area at the Ultradistal Radius(Baseline and days 29, 57, 85, 127, and 169)
  • Maximum Serum Concentration (Cmax) of Romosozumab(First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)
  • Area Under the Serum Concentration-time Curve From Time 0 to Tau (AUC0-28)(First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)
  • Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf)(Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)
  • Apparent Clearance (CL/F) of Romosozumab(Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)
  • Terminal Half-life (t1/2,z) of Romosozumab(Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)
  • Accumulation Ratio(First Dose: Day 1 (predose) and on days 4, 15, and 29 (predose). Last Dose: Days 57 (predose), 62, 71, 85, 99, 127, and 169)

研究者

发起方
Amgen
申办方类型
Industry
责任方
Sponsor

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