A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 643
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis
研究概览
简要总结
This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory postmenopausal women.
- •Age 55 years or older
- •Subject has provided informed consent prior to any study specific procedures
- •Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to screening visit
- •Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of equal to or less than those listed in the protocol.
- •At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray absorptiometry (DXA) at the screening visit
排除标准
- •Received other osteoporosis treatment or bone active treatment
- •Evidence of history of any of the following:
- •hyperthyroidism (stable on antithyroid therapy is allowed)
- •hypothyroidism (stable on thyroid replacement therapy is allowed)
- •hypo- or hyperparathyroidism
- •hypo- or hypercalcemia based on the central laboratory reference ranges
- •Recent tooth extraction (within 6 months of screening visit)
- •Paget disease of bone (subject report or chart review)
- •other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
- •Abnormalities of the following per central laboratory reference ranges:
- •vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be allowed and subjects may be re-screened
- •hypercalcemia
- •elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
- •History of any solid organ or bone marrow transplant
- •Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
- •Known intolerance to calcium or vitamin D supplements
- •Self-reported alcohol or drug abuse within 12 months prior to screening
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
- •History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
研究组 & 干预措施
Denosumab 60 mg
Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
干预措施: Denosumab (Biological)
Denosumab 60 mg
Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
干预措施: Placebo to Zoledronic Acid (Drug)
Zoledronic Acid 5 mg
Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
干预措施: Zoledronic Acid (Drug)
Zoledronic Acid 5 mg
Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
干预措施: Placebo to Denosumab (Drug)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis
时间窗: Baseline and Month 12
Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.
次要结局
- Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis(Baseline and Month 12)
- Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis(Baseline and Month 12)
- Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis(Baseline and Month 12)