The Optimal Long Term Treatment Strategy of Anti-resorptive Medications
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in lumbar spine bone mineral density
研究概览
简要总结
This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.
详细描述
This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.
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
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women or men over 50 years old with osteoporosis or osteopenia leading to fractures.
- •Denosumab treatment for at least two years and less than three years (up to maximum of five doses).
排除标准
- •Secondary osteoporosis.
- •Metabolic bone diseases.
- •Malignancy.
- •Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
- •Patients had ever used antiosteoporosis medications other than Dmab
- •Estimated glomerular filtration rate < 35 mL/min.
- •Allergy to Zoledronate.
- •Any other contraindications to Zoledronate use.
- •History of diagnosed hypocalcemia.
- •Age greater than 80 years.
研究组 & 干预措施
Persistent treatment of Denosumab:
persistent denosumab for 7 years
干预措施: Continuous Denosumab (Drug)
Alternating treatment of Denosumab and Zoledronic acid
Alternating treatment with denosumab and zoledronic acid over a 7-year period: after entering the trial, patients received one year of zoledronic acid, followed by two years of denosumab, then switched back to zoledronic acid for one year, followed by another two years of denosumab, and finally received one more year of zoledronic acid.
干预措施: Administer zoledronate and denosumab on an alternating schedule (Drug)
结局指标
主要结局
Change in lumbar spine bone mineral density
时间窗: From enrollment to the end of treatment at 3 years
次要结局
- Change in total hip bone mineral density(From enrollment to the end of treatment at 3 years and 7 years)
- Change in femoral neck bone mineral density(From enrollment to the end of treatment at 3 years and 7 years)
- Change in lumbar spine bone mineral density(From enrollment to the end of treatment at 7 years)
- Change in C-terminal telopeptide of type 1 collagen(From enrollment to the end of treatment at 3 years and 7 years)
- Change in Procollagen type 1 N-terminal propeptide(From enrollment to the end of treatment at 3 years and 7 years)
- Fractures(3 & 7 years)
- Change in quality of life(From enrollment to the end of treatment at 3 years and 7 years)
研究者
National Taiwan University Clinical Trial Center
National Taiwan University Hospital Yunlin Branch, Orthopedic department
National Taiwan University Hospital