停用狄诺塞麦和芳香化酶抑制剂治疗的绝经后乳腺癌患者骨并发症的观察研究
接受芳香化酶抑制剂和狄诺塞麦治疗的绝经后乳腺癌患者：一项评估停用狄诺塞麦后反弹性骨丢失和不全性骨折的观察性研究
The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.
研究概览
地位
条件
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Monica Fornier, MD
- 电话号码：646-888-4563
- 邮箱：fornierm@mskcc.org
研究联系人备份
- 姓名：Azeez Farooki, MD
- 电话号码：646-608-3798
- 邮箱：farookia@mskcc.org
学习地点
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New Jersey
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Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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接触：
- Monica Fornier, MD
- 电话号码：646-888-4563
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Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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接触：
- Monica Fornier, MD
- 电话号码：646-888-4563
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Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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接触：
- Monica Fornier, MD
- 电话号码：646-888-4563
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New York
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Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
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接触：
- Monica Fornier, MD
- 电话号码：646-888-4563
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Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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接触：
- Monica Fornier, MD
- 电话号码：646-888-4563
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New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center
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接触：
- Monica Fornier, MD
- 电话号码：646-888-5240
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Uniondale、New York、美国、11553
- 招聘中
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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接触：
- Monica Fornier, MD
- 电话号码：646-888-4563
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients will be recruited through the Breast Medicine and Survivorship Services. Members of the research team will verify eligibility against the patient's medical record. Once eligibility is confirmed, and if the treating investigator has no objection to enrolling the patient in the research study, the patient will be approached for consent. Consent to the protocol will be conducted by a trained consenting professional. Consent will take place either in the clinic, or by following the most updated standard working procedures for consent via telemedicine.
描述
Inclusion Criteria:
- Women with Stage 0-3 breast cancer confirmed at MSKCC
- Currently have no clinical evidence of disease
- Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment
- Received at least 2 doses of denosumab and then discontinued therapy
- Discontinued AI prior to or within 6 months of last denosumab injection
- Patients must be 18 years of age or olde
Exclusion Criteria:
- Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;
- Patients with history of insufficiency fracture.
- Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab
- Patients on chronic low-dose glucosteroids.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Post- menopausal breast cancer patients
Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab |
Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed). Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.
其他名称：
TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in serum carboxy-terminal collagen crosslinks (CTX)
大体时间：12 months
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Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX) |
12 months
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Change in bone specific alkaline phosphatase (ALK)
大体时间：12 months
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Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK) |
12 months
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合作者和调查者
调查人员
- 首席研究员：Monica Fornier, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 22-280
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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