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临床试验 NCT01419730 针对Bone Metabolism Biomarkers，骨密度，身体健康目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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罗彻斯特大学Vitamin D and Physical Activity on Bone Health
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“解释临床试验”即可查看和讨论您选择的语言的试验信息。
临床试验NCT01419730旨在研究治疗，主要针对Bone Metabolism Biomarkers，骨密度，身体健康。这是一项II期 (第二期) 干预性研究试验，目前试验状态为进行中但不再招募。试验始于2011年8月1日，计划招募191名患者。该研究由罗彻斯特大学主导，预计于2025年12月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年6月4日。
简要概括
This research will examine the effectiveness of vitamin D or placebo (the placebo is a tablet that looks like Vitamin D study drug, but has no Vitamin D study drug in it), with and without physical activity (walking and progressive resistance exercise), in treating bone loss in women who have undergone treatment for breast cancer. The investigators would also like to find out if the physical activity program improves cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and balance. One hundred five (105) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.
官方标题
The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy
疾病
Bone Metabolism Biomarkers骨密度身体健康其他研究标识符
- 34834
NCT编号
实际开始日期
2011-08
最近更新发布
2025-06-04
预计完成日期
2025-12-30
计划入组人数
191
研究类型
干预性研究
试验分期 (阶段)
II期 (第二期)
试验状态
进行中但不再招募
主要目的
治疗方法
分配方式
随机
干预模型
析因设计
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Vitamin D3 50,000 IU Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks. | 维生素D3 Vitamin D3 50,000 IU |
阳性对照Vitamin D3 50,000 IU and Physical Activity Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks. | 维生素D3 Vitamin D3 50,000 IU 体育活动 Progressive walking and resistance band exercise prescription for a period of 24 weeks |
无干预Control Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Measure the amount of bone loss in non-metastatic breast cancer patients receiving a high dose vitamin D therapy along with a structured home-based walking and progressive resistance exercise program. | To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone metabolism biomarkers in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months.
To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months. | 24 weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Measure the effect of vitamin D and exercise on physical fitness in non-metastatic breast cancer patients | Measuring physical fitness includes balance, aerobic capacity, and muscle strength in non-metastatic breast cancer patients who begin hormonal therapy within the previous 12 months. | 24 weeks |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
女性
- Must be female and have a primary diagnosis of Stage I, II, or III hormone-receptor positive breast cancer.
- Women must be postmenopausal at time of enrollment.
- Must provide informed consent.
- Must be willing to discontinue use of calcium and/or vitamin D supplements.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.6 mg/dl.
- Participants must be slightly vitamin D deficient (serum vitamin D level <32ng/ml)
- Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.132
- Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 24-week supplementation of vitamin D.
- Must be less than five years from the diagnosis of breast cancer and must be within 12 months of starting treatment with aromatase inhibitors (AI) in accordance with American Society of Clinical Oncology (ASCO) guidelines.
- Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.
- Patients who had a myocardial infarction within the past year.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
- Patients with hypercalcemia (corrected serum Ca ≥ 10.6 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
- Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.
- Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
- Patients with a known sensitivity to vitamin D.
- Patients who are severely vitamin D deficient (<10 ng/ml).
- Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
- Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.
- Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
罗彻斯特大学194 个活跃的临床试验可供探索研究责任方
Luke Peppone, 主要研究者, Assistant Professor, University of Rochester
没有联系数据。
1 位于 1 个国家/地区的研究中心
New York
University of Rochester, Rochester, New York, 14642, United States