A Randomized Phase II of Zoledronic Acid (Zometa) in the Prevention of Osteoporosis in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Mean Change in Bone Mineral Density
研究概览
简要总结
RATIONALE: Zoledronic acid, vitamin D, and calcium may prevent bone loss in patients who are undergoing donor stem cell transplant.
PURPOSE: This randomized phase II trial is studying how well zoledronic acid works in preventing osteoporosis in patients undergoing donor stem cell transplant.
详细描述
OBJECTIVES:
Primary
- Evaluate whether prophylactic administration of zoledronic acid can reduce the severity of bone mineral loss in patients undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
- Determine the safety of zoledronic acid in these patients.
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
- None
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
- •Patient age ≥18 years
- •Undergoing allogeneic hematopoietic stem cell transplantation (HCT) from any stem cell source with either a myeloablative or non-myeloablative conditioning regimen
- •Bone mineral density measured by baseline pre-transplant DEXA scan in the osteopenic range (defined as a T-score between -1 and -2.5 standard deviation (SD) at either the lumbar spine or the proximal femur or both)
- •Adequate renal function defined as: Calculated creatinine clearance of ≥ 60 ml/min using the Cockcroft-Gault formula:
- •Serum calcium (corrected) of ≤ 10.5 mg/dl
- •Patients (male or female) of reproductive potential are required to use a medically acceptable contraception while receiving zoledronic acid (if assigned study drug).
- •Normal dental exam within the year prior to study registration
- •Informed signed consent to participate in the study
排除标准
- •Pre-existing metabolic bone disease including osteomalacia, hyperparathyroid bone disease, osteogenesis imperfecta, Paget's disease, rickets, or hypoparathyroidism.
- •Multiple myeloma
- •History of nontraumatic vertebral compression fractures
- •History of the following endocrine disorders - hyperparathyroidism, hyperthyroidism.
- •Malabsorption syndrome including Crohn's disease.
- •Chronic liver disease
- •Concomitant regular use of phenytoin.
- •Known hypersensitivity to zoledronic acid (Zometa) or other biphosphonates
- •Biphosphonate therapy within the preceding six months.
- •Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- •Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- •Not pregnant or breastfeeding since zoledronic acid is classified as Pregnancy Category C: risk in pregnancy cannot be ruled out. A negative pregnancy test is required within 7 days of registration if pre- or perimenopausal (i.e., last menstrual period within one year of registration). Because it is not known whether zoledronic acid is excreted in breast milk, breastfeeding is not permitted while receiving study drug.
研究组 & 干预措施
Arm I (control)
Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
干预措施: calcium (Dietary Supplement)
Arm I (control)
Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
干预措施: cholecalciferol (Dietary Supplement)
Arm II (treatment)
Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
干预措施: calcium (Dietary Supplement)
Arm II (treatment)
Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
干预措施: cholecalciferol (Dietary Supplement)
Arm II (treatment)
Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
干预措施: zoledronic acid (Drug)
结局指标
主要结局
Mean Change in Bone Mineral Density
时间窗: From Time of Transplant to 12 Months Post-Transplant
Change in bone mineral density of the femoral neck measured from baseline to 12 months after transplant utilizing Dual-energy X-ray absorptiometry (DEXA) scan. Comparison of difference between the standard of care group (receiving calcium and vitamin D)and the Zometa group. The measurement consists of baseline bone mineral density measurements with followup measurements at 12 months. This will be analyzed as a continuous variable. Percent change in bone mineral density (BMD) will be calculated as (BMD change) x 100/BMD baseline.
次要结局
- Mean Change in Luteinizing Hormone(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Serum Osteocalcin(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Urinary N-terminal Telopeptide(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Follicle-Stimulating Hormone(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Thyroid Function Test 4(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Ultrasensitive Estradiol(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Serum Bone Specific Alkaline Phosphate(From Time of Transplant to 12 Months Post-Transplant)
- Mean Change in Total Testosterone(From Time of Transplant to 12 Months Post-Transplant)