A Phase II Multicenter, Single Arm, Open-Label Trial to Evaluate the Efficacy and Safety of Denosumab in Treatment of Post-Allogenic Hematopoietic Stem Cell Transplant Bone Loss
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Mean Total Hip Percent Change in Bone Mineral Density (BMD)
研究概览
简要总结
This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the efficacy and safety of denosumab therapy for the treatment of bone loss in patients who have received an allogeneic hematopoietic stem cell transplant.
OUTLINE:
Patients receive 2 doses of denosumab subcutaneously (SC) between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.
After completion of study treatment patients are followed up at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •The patient has undergone an Allogeneic Hematopoietic Stem Cell Transplant
- •The patient has completed a base line dual x-ray absorptiometry (DXA) scan =< 6 months prior to transplantation
- •The patient has completed a post-transplant DXA scan at day 100 (+/- 30 days) or up to 6 months post transplantation
- •The patient has completed and passed a dental clearance exam up to 6 months prior to transplant or 6 months after transplant
- •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •The patient has a history of a hypersensitivity reaction to denosumab
- •The patient has a history of osteonecrosis of the jaw
- •The patient has predisposing risk factors for hypocalcemia including the following:
- •Hypoparathyroidism
- •Creatinine clearance (CrCl) < 30 mL/min
- •Malabsorption syndrome
- •The patient has history of any bone fracture =< 30 days prior to denosumab therapy
- •Pregnant or nursing female patients.
- •The patient has clinically significant GVHD leading to hospitalization at the time of denosumab dose per prescriber discretion.
- •The patient has clinically significant infection leading to hospitalization at the time of denosumab dose (excluding hospitalization due to complexity of treatment leading to inability to treat outpatient, ie. Foscarnet) per prescriber discretion
- •The patient is unwilling or unable to follow protocol requirements
- •The patient has any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug including relapsed malignancy
结局指标
主要结局
Mean Total Hip Percent Change in Bone Mineral Density (BMD)
时间窗: At baseline, at time of enrollment (day 100 post-hematopoietic stem cell transplantation [HSCT])
Day 100 dual x-ray absorptiometry (DXA) scan will be compared based on the percent change in BMD in the Total hip in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.
Slope in Hip Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual
时间窗: From the time of enrollment up to 465 days post-HSCT
Parameter estimate of the slope of the regression model of the hip bone mineral density change at day 465 post-HSCT regressed on the enrollment BMD levels.
Slope in Lumbar Spine Bone Mineral Density (g/cm^2 Per Day) Regressed on Time in Dual
时间窗: From the time of enrollment up to 465 days post-HSCT
Parameter estimate of the slope of the regression model of the lumbar spine bone mineral density change at day 465 post-HSCT regressed on the enrollment BMD levels.
Mean Lumbar Spine Percent Change in Bone Mineral Density (BMD)
时间窗: At baseline and 465 days post-HSCT
Day 0 dual x-ray absorptiometry (DXA) scan and day 465 DXA scan will be compared based on the percent change in BMD in lumbar spine in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.
次要结局
- Frequency of Bone Fractures(Up to 1 year post-HSCT)
- Mean Lumbar Spine Percent Change in BMD(Baseline up to 100 days post-HSCT)
- Number of Participants That Experienced Any AE(Up to 30 days)