A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Safety, Tolerability and Efficacy of AGA2118 in Postmenopausal Women With Low Bone Mineral Density
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 379
- 试验地点
- 26
- 主要终点
- Percent change from Baseline to Month 12 in lumbar spine bone mineral density
研究概览
简要总结
The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.
详细描述
This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or femoral neck and no prior history of fragility fractures.
This study includes a 12 month blinded treatment phase where participants will be randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo. At Month 12, participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen, receive a new dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12 to 24.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤
- •BMD T-score of ≤ -2.5 to > -3.5 at the lumbar spine, total hip, or femoral neck.
排除标准
- •History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.
- •Vitamin D deficiency.
- •Known intolerance to calcium or vitamin D supplements.
- •Untreated hyper- or hypothyroidism.
- •Current hyper- or hypoparathyroidism.
- •Elevated transaminases.
- •Significantly impaired renal function.
- •Current hypo- or hypercalcemia.
- •Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.
- •Malignancy within the last 5 years.
- •Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.
- •Myocardial infarction or stroke within the past 12 months.
- •Use of agents affecting bone metabolism.
研究组 & 干预措施
AGA2118 Dose Regimen 1
AGA2118 selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: AGA2118 (Drug)
AGA2118 Dose Regimen 2
AGA2118 selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: AGA2118 (Drug)
AGA2118 Dose Regimen 3
AGA2118 selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: AGA2118 (Drug)
AGA2118 Dose Regimen 4
AGA2118 selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: AGA2118 (Drug)
AGA2118 Dose Regimen 5
AGA2118 selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: AGA2118 (Drug)
AGA2118 Dose Regimen 6
AGA2118 selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: AGA2118 (Drug)
Placebo Regimen
Placebo selected dose
Participants that complete the double-blind period from study start to Month 12 will continue on to a 12 month open-label period. They will be re-randomized for Months 12 to 24.
干预措施: Placebo (Other)
结局指标
主要结局
Percent change from Baseline to Month 12 in lumbar spine bone mineral density
时间窗: 12 months
To determine the effect of treatment with AGA2118 versus placebo at Month 12 on the percent change from Baseline in bone mineral density at the lumbar spine in postmenopausal women with low bone mineral density
次要结局
- Percent change from Baseline to Months 3 and 6 in lumbar spine, total hip, femoral neck, and one-third distal radius bone mineral density(3 and 6 months)
- Percent change from Baseline to Month 12 in total hip, femoral neck, and one-third distal radius bone mineral density(12 months)
- Percent change from Baseline to Months 1, 3, 6, 9, and 12 in P1NP and CTX-1(1, 3, 6, 9, and 12 months)
- Incidence of new clinical fractures (vertebral and nonvertebral) between Baseline and Month 12(12 months)