Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Serum c-telopeptide (CTX)
研究概览
简要总结
Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.
Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.
This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women aged 45+
- •postmenopausal
- •osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines
排除标准
- •no significant previous use of bone health modifying treatments
- •hip fracture within one year of enrollment
- •known congenital or acquired bone disease other than osteoporosis
- •significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
- •abnormal calcium or parathyroid hormone level
- •serum vitamin D <20 ng/dL
- •anemia (hematocrit <32%)
- •history of malignancy (except non-melanoma skin carcinoma)
- •excessive alcohol use or substance abuse
- •extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
- •known contraindications to denosumab, alendronate, or raloxifene
研究组 & 干预措施
Denosumab and Raloxifene
denosumab and raloxifene
干预措施: denosumab (Drug)
Denosumab and Raloxifene
denosumab and raloxifene
干预措施: raloxifene (Drug)
Denosumab and Alendronate
denosumab and alendronate
干预措施: denosumab (Drug)
Denosumab and Alendronate
denosumab and alendronate
干预措施: alendronate (Drug)
结局指标
主要结局
Serum c-telopeptide (CTX)
时间窗: Month 12 to 18 months
Change in serum CTX between month 12 and month 18
Bone mineral density (BMD)
时间窗: Month 24 to 36 months
Change in PA spine BMD between month 24 and month 36
次要结局
未报告次要终点
研究者
Joy Tsai
Assistant Professor, Harvard Medical School
Massachusetts General Hospital