NCT04366726已完成1 期
A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
研究概览
简要总结
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
详细描述
This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal for at least 2 years
- •BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)
- •Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2)
- •Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
- •Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)
排除标准
- •History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine
- •History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease)
- •History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
- •History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year
- •Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84)
- •Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment
- •Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer
结局指标
主要结局
Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29
时间窗: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29
Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29
时间窗: 0 (predose) and 4 hours postdose on Day 29
次要结局
- Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29(Baseline, 0 (predose) and 4 hours postdose on Day 29)
- Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29(Baseline, 0 (predose) and 4 hours postdose on Day 29)
- Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29(Baseline, 0 (predose) and 30-minutes postdose on Day 29)
- Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29(Baseline, Day 29)
研究者
研究点 (2)
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