High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 51
- 主要终点
- Reduction of bone mineral density (BMD) loss as measured at the total hip
研究概览
简要总结
This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).
II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.
SECONDARY OBJECTIVES:
I. To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, study coordinators, and investigators will be blinded to high-dose vitamin D or placebo group assignments.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)
- •Be age 50 years or older
- •Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone [LHRH] antagonists and LHRH agonists are permitted)
- •Have a total serum vitamin D between 10 and 32 ng/ml
- •Have a total serum calcium of less than or equal to 10.5 mg/dl
- •Have a normal GFR (glomerular filtration rate > 30ml)
- •Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study
- •Be able to provide written informed consent
- •Be able to swallow pills and capsules
- •Be able to speak and read English
排除标准
- •Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment
- •Have a diagnosis of stage IV chronic kidney disease
- •Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
- •Have a history of hypercalcemia or vitamin D toxicity/sensitivity
研究组 & 干预措施
Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Dual X-ray Absorptiometry (Procedure)
Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Placebo Administration (Drug)
Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Dual X-ray Absorptiometry (Procedure)
Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Quality-of-Life Assessment (Other)
Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Questionnaire Administration (Other)
Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Quality-of-Life Assessment (Other)
Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Biospecimen Collection (Procedure)
Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Biospecimen Collection (Procedure)
Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: D Vitamin (Dietary Supplement)
Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Reduction of bone mineral density (BMD) loss as measured at the total hip
时间窗: At 52 weeks
Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total hip via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of covariance (ANCOVA) with group (vitamin D or placebo) as the main factor, baseline timepoint (\[T\]1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial linear mixed model (LMM) will be fit using Restricted Maximum Likelihood (REML) estimation. The significance of the variance due to study site will be tested using the Wald Test.
Reduction of BMD loss as measured at the femoral neck
时间窗: At 52 weeks
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the femoral neck via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.
Reduction of BMD loss as measured at the distal radius
时间窗: At 52 weeks
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the distal radius via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.
Reduction of BMD loss as measured at the lumbar spine
时间窗: At 52 weeks
Will determine the efficacy of HDVD supplementation versus placebo in reducing BMD loss as measured at the lumbar spine via DXA at 52 weeks. Will use ANCOVA with group (vitamin D or placebo) as the main factor, baseline (T1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial LMM will be fit using REML estimation. The significance of the variance due to study site will be tested using the Wald Test.
次要结局
- Change in falls(Baseline up to 52 weeks)
- Change in fractures(Baseline up to 52 weeks)
- Change in quality of life(Baseline up to 52 weeks)
研究者
Luke Peppone
URCC Study Chair
University of Rochester NCORP Research Base