A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of BA058 Administered Via a Coated Transdermal Microarray Delivery System (BA058 Transdermal) in Healthy Postmenopausal Women With Osteoporosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
研究概览
简要总结
To determine the clinical safety and efficacy of abaloparatide transdermal in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD) and serum markers of bone metabolism when compared to transdermal placebo and abaloparatide injection for 6 months of treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Since the abaloparatide injection arm was administered subcutaneously (SC), it was not possible to blind this arm of the study. Therefore, abaloparatide-SC was considered a reference drug, but the centralized BMD assessments and bone marker evaluations remained blinded to all treatment assignments.
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal woman, less than 85 years old.
- •BMD T-score ≤-2.5 of spine or hip (femoral neck) or ≤-2.0 with previous fracture (within 5 years).
- •Normal physical exam, vital signs, electrocardiogram (ECG), and medical history.
- •Laboratory tests within the normal range, including serum calcium, Vitamin D, parathyroid hormone (PTH) (1-84), serum phosphorus, and alkaline phosphatase.
排除标准
- •BMD T-score ≤-5.0 at the lumbar spine or hip.
- •History of bone disorders (for example, Paget's disease) other than postmenopausal osteoporosis.
- •Significantly impaired renal function.
- •History of any cancer.
研究组 & 干预措施
Abaloparatide Transdermal (50 mcg)
Abaloparatide Transdermal Microneedle Patch - 50 microgram (mcg) daily applications for up to 6 months
干预措施: Abaloparatide Transdermal (50 mcg) (Drug)
Abaloparatide Transdermal (100 mcg)
Abaloparatide Transdermal Microneedle Patch - 100 mcg daily applications for up to 6 months
干预措施: Abaloparatide Transdermal (100 mcg) (Drug)
Abaloparatide Transdermal (150 mcg)
Abaloparatide Transdermal Microneedle Patch - 150 mcg daily applications for up to 6 months
干预措施: Abaloparatide Transdermal (150 mcg) (Drug)
Abaloparatide Injection (80 mcg)
Abaloparatide-SC Subcutaneous Injection - 80 mcg daily injections for up to 6 months
干预措施: Abaloparatide Injection (80 mcg) (Drug)
Abaloparatide Transdermal Placebo (0 mcg)
Abaloparatide Transdermal Microneedle Patch - 0 mcg daily applications for up to 6 months
干预措施: Abaloparatide Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at 6 Months
时间窗: Baseline, 6 Months
Percent change in BMD as specified by dual energy x-ray absorptiometry (DXA) scans of the lumbar spine.
次要结局
- Percent Change From Baseline in Serum Procollagen Type I C Propeptide (PICP) at 6 Months(Baseline, 6 Months)
- Percent Change From Baseline in BMD of Total Hip at 6 Months(Baseline, 6 Months)
- Percent Change From Baseline in Serum Osteocalcin at 6 Months(Baseline, 6 Months)
- Percent Change From Baseline in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (CTXI) at 6 Months(Baseline, 6 Months)
- Number of Participants With Abnormal Physical Examinations at Screening and End of Treatment (6 Months)(Baseline up to 6 Months)
- Percent Change From Baseline in BMD of Forearm at 6 Months(Baseline, 6 Months)
- Percent Change From Baseline in Serum Bone-Specific Alkaline Phosphatase (BSAP) at 6 Months(Baseline, 6 Months)
- Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Result(Baseline up to 7 Months)
- Number of Participants With an Abnormal Clinical Coagulation Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4(Baseline up to 6 Months)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) That Occurred During the Study That Were Associated With Vital Sign Changes(Baseline up to 7 Months)
- Number of Participants With an Abnormal Clinical Chemistry Laboratory Parameter With an ECOG Score of Grade 3 or Grade 4(Baseline up to 6 Months)
- Percent Change From Baseline in Serum Procollagen Type I N Propeptide (PINP) at 6 Months(Baseline, 6 Months)
- Number of Participants With an Abnormal Clinical Hematology Laboratory Parameter With an Eastern Cooperative Oncology Group (ECOG) Score of Grade 3 or Grade 4(Baseline up to 6 Months)