A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Denisty

Amgen0 个研究点目标入组 1,189 人2006年5月

适应症Osteoporosis Osteopenia

干预措施Alendronate Denosumab

概览

阶段: 3 期
干预措施: Alendronate
疾病 / 适应症: Osteoporosis
发起方: Amgen
入组人数: 1189
主要终点: Total Hip Bone Mineral Density Percent Change From Baseline at Month 12
状态: 已完成
最后更新: 15年前

概览研究者入排标准研究组 & 干预措施结局指标相似试验

概览

简要总结

The purpose of this study is to determine whether in postmenopausal women with low bone mineral density, the mean percent change in total hip BMD in subjects receiving denosumab is not less than that observed in subjects receiving alendronate sodium by more than a pre-specified non-inferiority margin.

注册库

clinicaltrials.gov

开始日期

2006年5月

结束日期

2008年1月

最后更新

15年前

研究类型

Interventional

研究设计

Parallel

性别

Female

研究者

发起方

Amgen

入排标准

入选标准

•Patient is an ambulatory postmenopausal woman - Patient has BMD value that corresponds to a T-score of less than or equal to -2.0 (g/cm2) at the lumbar spine OR total hip within range specific to the study protocol.

排除标准

•o Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
•Evidence of any of the following per subject report, chart review or central laboratory result:
•Hyper- or hypothyroidism; however, subjects on stable thyroid hormone replacement therapy may be allowed per the following criteria:
•If TSH level is normal, subject is eligible for the study.
•If TSH level is below normal range, subject is not eligible for the study.
•If TSH level is elevated (\> 5.5 mIU/mL to 10.0 mIU/mL), serum T4 should be measured. If serum T4 is within normal range, subject is eligible. If serum T4 is outside of normal range, subject is not eligible for the study.
•If TSH level is above 10.0 mIU/mL, subject is not eligible.
•Current hyper- or hypoparathyroidism
•Elevated transaminases
•Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase \[SGOT\]) ³ 2.0 x upper limits of normal (ULN)

研究组 & 干预措施

Alendronate

Subjects in this arm will receive active ALN and placebo denosumab

干预措施: Alendronate

Denosumab

Subjects in this arm will receive active denosumab and placbo ALN

干预措施: Denosumab

结局指标

主要结局

Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

时间窗: 12 months

Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

次要结局

Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12(12 months)
Trochanter Bone Mineral Density Percent Change From Baseline at Month 12(12 months)
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12(12 months)
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12(12 months)