A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 79
- 主要终点
- Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
研究概览
简要总结
To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory, postmenopausal women
- •Randomized to either denosumab or placebo in the 20050179 (NCT00293813) study and completed that study (ie, attended an end of study visit)
- •At least 12 months have elapsed since their end of 20050179 study visit
- •Provide signed informed consent
排除标准
- •Subjects who failed to receive both doses of denosumab (or SQ [subcutaneous] placebo) during the 20050179 study
- •Subjects who were randomized to the alendronate arm during the 20050179 study
- •Subjects diagnosed with any of the following conditions following completion of the 20050179 study:
- •Hyperthyroidism
- •Hyperparathyroidism
- •Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)
- •Any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy
- •Other diseases which affect bone metabolism
- •Self-reported alcohol or drug abuse within the previous 12 months
- •Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
- •Received any investigational product other than denosumab in two years before the screening visit.
- •Received > 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study.
- •Current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone.
- •Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than Amgen trial 20080287), or subject is receiving other investigational agent(s).
研究组 & 干预措施
Arm 1
Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
干预措施: Denosumab (Biological)
Arm 1
Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
干预措施: high-resolution peripheral quantitative computed tomography (HR-pQCT) (Procedure)
Arm 1
Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
干预措施: Dual energy X-ray absorptiometry (DXA) (Procedure)
Arm 1
Participants who were randomized to either denosumab or placebo in Study 20050179 and at least 12 months had elapsed from their 20050179 end-of-study visit had dual energy X-ray absorptiometry (DXA) of the forearm and HR-pQCT of the tibia and radius on Day 1 of this study. No study drug was administered.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Radius by HR-pQCT
时间窗: Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.
Percent change from the 20050179 Baseline in cortical thickness at the distal radius as determined by high-resolution peripheral quantitative computed tomography (HR-pQCT) at an average of 32 months since the last subcutaneous dose of denosumab or placebo in study 20050179.
次要结局
- Percent Change From the Parent Study Baseline in Total Bone Mineral Density (BMD) at the Distal Radius by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Radius by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Radius by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change From the Parent Study Baseline in Cortical Thickness at the Distal Tibia by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change From the Parent Study Baseline in Cortical BMD at the Distal Tibia by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change From the Parent Study Baseline in Total BMD at the Distal Tibia by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change From the Parent Study Baseline in Trabecular BMD at the Distal Tibia by HR-pQCT(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change of Distal 1/3 Radius BMD From the Parent Study Baseline by DXA(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change of Ultradistal Radius BMD From the Parent Study Baseline by DXA(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Percent Change of Total Radius BMD From the Parent Study Baseline by DXA(Baseline of Study 20050179 and Day 1 of this study. Study 20050179 duration was up to 12 months and the median time since completion of Study 20050179 was 32 months.)
- Actual Value of Serum Type I C-telopeptide(Day 1)
- Actual Value of Procollagen Type 1 N-terminal Peptide(Day 1)