The Impact of Osteoporosis Medications on Muscle Health in Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in appendicular lean mass (ALM/body mass index)
研究概览
简要总结
Osteosarcopenia is a geriatric musculoskeletal syndrome characterized by co-existence of osteoporosis and sarcopenia (low skeletal muscle mass, strength, and/or functional capacity). There is strong evidence of overlap between the pathophysiology of osteoporosis and sarcopenia (muscle-bone crosstalk). This research plan will further explore the relationship between bone and muscle, and provide new information about effect of osteoporosis medications on muscle health in older adults who are under treatment for osteoporosis.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory adults age ≥65 years including those using assistive devices to maximize generalizability, if they have criteria for treating osteoporosis including:
- •Osteoporosis by axial bone density (spine, hip or forearm BMD T-score ≤-2.5 SD) or
- •A previous adult fragility fracture of the spine or hip or
- •Would be treated based on FRAX National Osteoporosis Foundation treatment thresholds of a 10-year risk of ≥ 20% for a major osteoporotic fracture or ≥ 3% for hip fracture using femoral neck BMD.
排除标准
- •Patients with a calculated creatinine clearance < 35 ml/min or
- •Who have a contraindication for bisphosphonates or denosumab or
- •Those who are scheduled for a tooth extraction to avoid jaw osteonecrosis or
- •Subjects with severe liver disease or
- •Those who have been on oral bisphosphonates for the past 1 year and intravenous bisphosphonates for the past 2 years prior to the study or
研究组 & 干预措施
Denosumab
干预措施: Zoledronic Acid Placebo (Other)
Zoledronic Acid
干预措施: Denosumab Placebo (Other)
Zoledronic Acid
干预措施: Zoledronic Acid (Drug)
Denosumab
干预措施: Denosumab (Drug)
结局指标
主要结局
Percentage change from baseline in appendicular lean mass (ALM/body mass index)
时间窗: Baseline vs Month 12
Appendicular lean mass is measured by whole body DXA scan and is an index of skeletal muscle mass
Percentage change from baseline in gait speed (m/s)
时间窗: Baseline vs Month 12
Gait speed is a measure of muscle function and will be measured by standard 4 meter gait speed test
Percentage change from baseline in muscle mass (kg) measured by D3-Creatine
时间窗: Baseline vs Month 12
D3-Creatine dilution method is a novel method to measure muscle mass
Percentage change from baseline in bone mineral density (BMD) (g/cm²)
时间窗: Baseline vs Month 12
BMD is measured by a DXA scan system and a higher BMD is correlated with lower fracture risk
Percentage change from baseline in rectus femoris muscle thickness (cm)
时间窗: Baseline vs Month 12
This variable will be measured by ultrasound
Percentage change from baseline in rectus femoris muscle cross-sectional surface area (cm²)
时间窗: Baseline vs Month 12
This variable will be measured by ultrasound
Percentage change from baseline in trabecular bone score (TBS)
时间窗: Baseline vs Month 12
TBS is measure of bone microarchitecture and is measured by a DXA system. A value of ≥ 1.35 indicates a normal architecture while TBS ≤ 1.20 indicates degraded microarchitecture
Percentage change from baseline in grip strength (kgf)
时间窗: Baseline vs Month 12
Grip strength is measure of muscle strength and will be measured by a standard hand dynamometer
次要结局
未报告次要终点
研究者
Nami Safai Haeri
Assistant Professor
University of Pittsburgh