NCT03432533已完成3 期
A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab Via Autoinjector/Pen vs Healthcare Provider-administered Romosozumab Via Prefilled Syringe
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Lumbar Spine BMD at Month 6
研究概览
简要总结
To evaluate the noninferiority of a 6-month treatment with 210 mg romosozumab at 90 mg/mL administered subcutaneously (SC) once a month (QM) in postmenopausal women with osteoporosis either by healthcare provider (HCP) administration with prefilled syringe (PFS) or by subject self-administration with autoinjector/pen (AI/Pen)
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
- None
盲法说明
This is an open-label study; blinding procedures are not applicable.
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent/assent prior to initiation of any studyspecific activities/procedures, or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •Postmenopausal female (postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening)
- •≥ 55 to ≤ 90 years of age at the time of informed consent
- •Ambulatory
- •BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans -Subject has at least 2 vertebrae in the L1-L4 region evaluable by DXA, as assessed by the principal investigator or designee
- •Subject has at least 1 hip evaluable by DXA, as assessed by the principal investigator or designee
- •Subject has history of fragility (ie, osteoporosis-related fracture) or subject meets at least 2 of the following clinical risk factors for fracture
- •≥ 70 years of age at the time of informed consent
- •BMD T-score ≤ -3.00 at the lumbar spine, total hip, or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
- •current smoker
- •consumption of ≥ 3 glasses of alcohol a day
- •parental history of fragility (ie, osteoporosis-related) fracture
- •body weight ≤ 125 pounds/56 kilogram
- •Ability to follow and understand instructions and the ability to self-inject, per investigator judgement
排除标准
- •History of osteonecrosis of the jaw and/or atypical femoral fracture
- •History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- •Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget's disease, sclerosteosis and osteopetrosis)
- •Vitamin D insufficiency [defined as serum 25 (OH) vitamin D levels < 20 ng/mL], as determined by the central laboratory. Vitamin D repletion will be permitted a nd subjects may be rescreened
- •Current hyperthyroidism (unless well controlled on stable antithyroid therapy) by subject report or by chart review, per principal investigator evaluation
- •Current clinical hypothyroidism (unless well controlled on stable thyroid replacement therapy) by subject report or by chart review, per principal investigator evaluation normal range, per subject medical history. Uncontrolled hyperparathyroidism is defined as: parathyroid hormone (PTH) outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects.
- •Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory. Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the ULN as assessed by the central laboratory
研究组 & 干预措施
Romosozumab 210 mg QM: PFS
Active Comparator
During the open-label treatment period, participants receive 210 mg romosozumab SC QM by HCP administration with PFS.
干预措施: romosozumab HCP administration with PFS (Drug)
Romosozumab 210 mg QM: AI/Pen
Active Comparator
During the open-label treatment period, participants receive 210 mg romosozumab SC QM by self-administration with AI/pen.
干预措施: romosozumab self-administration with AI/Pen (Device)
结局指标
主要结局
Percent Change From Baseline in Lumbar Spine BMD at Month 6
时间窗: Baseline, Month 6
Percent change from baseline in BMD at the lumbar spine as measured by dual-energy x-ray absorptiometry (DXA).
次要结局
- Percent Change From Baseline in Total Hip BMD at Month 6(Baseline, Month 6)
- Percent Change From Baseline in Femoral Neck BMD at Month 6(Baseline, Month 6)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Device-Related AEs, Discontinuations Due to AEs, and Deaths(up to Month 9 (-7/+3 days))
- Number of Participants Developing Anti-Romosozumab Antibodies(up to Month 9 (-7/+3 days))
研究者
研究点 (1)
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