Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- % change in Bone Mineral Density at the Femoral Neck
研究概览
简要总结
Patients who undergo bone marrow transplant for different types of cancer are exposed to many treatments such as steroids and whole body radiation. These treatments make the transplant possible but also make their bones weaker and more prone to fractures which can be a source of significant disability and decreased quality of life for cancer survivors. Our trial will investigate whether giving one dose of Zoledronic acid (a commonly used drug given to preserve bone mass in osteoporosis) before bone marrow transplant can protect from the bone loss caused by the transplant procedures. The investigators are also interested in studying the complex interactions of bone, muscle and fat which are greatly affected after bone marrow transplant.
详细描述
Primary Objective:
To determine whether a single dose of zoledronic acid pre-transplant will prevent HSCT-related bone loss without impeding engraftment, compared with placebo.
Secondary Objectives:
To identify bone and muscle deficits and alterations in fat distribution prior to HSCT, compared with healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First allogeneic HSCT
- •Age > 18 years
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Current or prior use of bone active medication (bisphosphonates, teriparatide, selective estrogen receptor modulators, or Denosumab)
- •Hypo- (Ca < 8.5 mg/dL) or hyper-calcemia (Ca > 10.5 mg/dL)
- •Hyperthyroidism (TSH < 0.4 mIU/L and free T4 > 1.6 ng/dL)
- •Hyperparathyroidism (PTH > 80 pg/mL)
- •Estimated GFR < 35 ml/min/1.73 m2
- •Other chronic disease unrelated to HSCT that may impact bone metabolism
- •Osteoporosis: patients with a history of fragility fracture, or a Hip or Spine T score of <-2.5 (these patients will be treated with Zoledronic Acid and followed, but excluded from randomization)
研究组 & 干预措施
Zoledronic acid arm
Zoledronic acid
干预措施: Zoledronic acid (Drug)
结局指标
主要结局
% change in Bone Mineral Density at the Femoral Neck
时间窗: 12 months
次要结局
未报告次要终点