Effect of Zoledronic Acid on Chemotherapy Induced Bone Loss in Non-Hodgkin's Lymphoma Patients Receiving Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months
研究概览
简要总结
Primary Objective:
- Evaluate the effect of zoledronate on change in bone mineral density (BMD) at the total lumbar spine and femoral neck.
Secondary Objectives:
- Evaluate the effect of zoledronate on change in BMD at the total hip
- Evaluate risk factors for developing osteoporosis on chemotherapy
- Determine correlative markers for response to zoledronate 4. Evaluate zoledronate effect on new bone fractures 5. Evaluate the cost-effectiveness of zoledronic acid (with calcium and vitamin D) versus standard treatment (calcium and vitamin D alone).
详细描述
Medicines called "bisphosphonates" have been shown to help people with cancer that has spread to their bones. Zoledronic acid is a "bisphosphonate". Some bisphosphonates are pills that can be swallowed. Other bisphosphonates such as zoledronic acid need to be given by vein (or intravenously). Some studies have shown that people with multiple myeloma, breast cancer, and prostate cancer that had spread to the bone had less side effects from their bone disease when they were treated with bisphosphonates by vein.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. Participants in one group will receive standard care with calcium and Vitamin D alone. Participants in the other group will receive standard care with calcium and Vitamin D plus zoledronic acid. There is an equal chance of being assigned to either group. Both you and your study doctor will know if you are being treated with zoledronic acid.
You will be asked to come to the doctor's clinic 5 times over about 12 months (at the start of the study [baseline] and then every 3 months). Each visit should take about 1 hour. Participants in the zoledronic acid group will receive an infusion of zoledronic acid by vein at baseline and at 6 months into the study. The infusion will last about 30 minutes. This infusion procedure may or may not be done at the same time as your already scheduled chemotherapy treatment.
You will take calcium and Vitamin D pills while on study at amounts recommended for prevention of osteoporosis.
You will have a physical exam done at every visit. Various x-rays and/or bone density scans will be repeated after 12 months. Your doctor may also want to do additional bone density or x-ray scans if you have new symptoms or your symptoms get worse.
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
- •Diagnosis of Non-Hodgkin's Lymphoma (B- or T-cell) or Hodgkin's lymphoma.
- •Prior Chemotherapy</= 4 weeks of treatment.
- •Age >/= 18 years old.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-
- •Estimated creatinine clearance >/= 60 ml/min.
- •Must sign an informed consent form.
排除标准
- •Radiologic evidence of vertebral or hip fracture.
- •BMD T-score less than (i.e., worse than or more negative than) -2.0 at any of the following sites: lumbar spine, femoral neck, or total hip.
- •Patients with secondary non-lymphomatous cancers metastatic to bone. However, other secondary cancers are allowed.
- •Spinal cord compression due to vertebral collapse.
- •Bisphosphonate treatment in the prior 6 months or steroid use (greater than 35 mg of prednisone equivalent steroids) in the prior 3 months. The use of topical, inhaled, or nasal steroids is allowed.
- •Primary hyperparathyroidism.
- •Active osteomalacia.
- •Untreated hypocalcemia (ionized, iCa), Ionized Ca level must be within normal limits prior to enrollment.
- •Untreated secondary hyperparathyroidism, Patients with abnormal parathyroid hormone (PTH) levels may be enrolled as long as they are being treated.
- •Untreated vitamin D deficiency, Vitamin D level may be abnormal and patient may be enrolled as long as they are being treated.
- •Untreated low testosterone (test in men only), testosterone level may be abnormal and patient may be enrolled as long as they are being treated.
- •Paget's disease.
- •Pregnant or breast-feeding.
- •Radiotherapy involving the mandible.
- •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), or of exposed bone in the mouth, or of slow healing after dental procedures.
- •Recent (within 3 weeks) or planned dental or jaw surgery (e.g.. extraction, implants).
- •Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of < 60 mL/minute.
- •Known hypersensitivity to zoledronic acid or other bisphosphonates.
- •Hypercalcemia: corrected Ca > 10.2 mg/dL or ionized Ca > 1.32 mmol/L
研究组 & 干预措施
Vitamin D + Calcium Carbonate
Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
干预措施: Vitamin D (Drug)
Vitamin D + Calcium Carbonate
Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
干预措施: Calcium Carbonate (Drug)
Vitamin D + Calcium Carbonate + Zoledronic Acid
Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
干预措施: Zoledronic Acid (Drug)
Vitamin D + Calcium Carbonate + Zoledronic Acid
Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
干预措施: Vitamin D (Drug)
Vitamin D + Calcium Carbonate + Zoledronic Acid
Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
干预措施: Calcium Carbonate (Drug)
结局指标
主要结局
Percentage Change in Bone Mineral Density (BMD) T-Score From Baseline to 12 Months
时间窗: From baseline to 12 Months
The 12-month change from baseline in BMD at the total lumbar spine. BMD evaluation was performed at baseline and at 12 months after initiation of therapy at the lumbar spine. BMD was measured by dual-energy, x-ray absorptiometry scanners. T-Score is the number of standard deviations above or below the mean. A T-score \>= -1 indicates a normal BMD, while T-scores between -1 and -2.5 indicate osteopenia and T-scores \<= -2.5 indicate osteoporosis.
次要结局
未报告次要终点