NCT06332014进行中（未招募）4 期
A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 102
- 试验地点
- 32
- 主要终点
- Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Ambulatory Chinese men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent.
- •Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture.
- •Have to have at least two intact vertebrae at baseline (L1-L4).
排除标准
- •Any condition that could affect bone metabolism such as Paget's disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed).
- •Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed.
- •Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed).
- •Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol.
- •Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months.
- •Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization.
- •Oral bisphosphonates treatment.
- •Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or cirrhosis of the liver.
- •Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason.
- •Oral/dental conditions that would require an intervention including tooth extraction during the course of the study and invasive dental work (per local oral surgeon's assessment) planned in the next 12 months.
- •Any prior use of products containing denosumab.
- •Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- •Vitamin D levels < 20 ng/mL (subjects are allowed into the study after vitamin D levels are corrected and subjects re-screened).
- •Albumin-adjusted serum calcium levels < 8.5 mg/dl or > 10.5 mg/dl.
研究组 & 干预措施
Prolia
Experimental
Participants will receive Prolia every six months (Q6M)
干预措施: Prolia (Drug)
结局指标
主要结局
Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12
时间窗: Baseline and Month 12
次要结局
- Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12(Baseline and Months 3, 6, 9, and 12)
- Percent change from baseline in lumbar spine BMD at month 6(Baseline and Month 6)
- Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12(Baseline and Months 3, 6, 9, and 12)
- Percent change from baseline in total hip and femoral neck BMD at month 6 and 12(Baseline and Months 6 and 12)
- Number of participants with adverse events (AE)(Up to 12 Months)
研究者
研究点 (32)
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