NCT07245381尚未招募1 期
A Pilot Study to Investigate the Use of Alendronate to Reduce the Risk of Pelvic Insufficiency Fractures in Cervical Cancer Patients Treated With Chemotherapy and Radiation Therapy
Dr. Itay GoorAryeh0 个研究点目标入组 65 人开始时间: 2025年12月1日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
- 主要终点
- Pain
研究概览
简要总结
Primary Objective
- Proof of concept: To evaluate the efficacy of alendronate in preventing pelvic insufficiency fractures (PIFs) in cervical cancer patients treated with chemo-radiotherapy over the short and long term. This objective will assess both the immediate and sustained effects of the drug on bone integrity through periodic bone mineral density measurements and clinical assessment of fracture incidence.
Secondary Objectives
- To assess the safety and tolerability of alendronate: This will involve monitoring and documenting any acute and chronic side effects associated with alendronate use in this patient population, including but not limited to gastrointestinal issues, renal function impairment, and osteonecrosis of the jaw.
- To document and analyze changes in quality of life: Using validated quality of life instruments, this objective will track changes in patient-reported outcomes, focusing on aspects such as pain levels, physical function, and overall well-being. This will help determine if the intervention not only prevents fractures but also contributes positively to the patients' quality of life during and after treatment.
- To explore correlations between patient-specific factors and treatment efficacy: This objective aims to understand how variables such as age, cancer stage, previous treatment history, and baseline bone health might influence the effectiveness of alendronate in preventing PIFs and enhancing bone mineral density.
详细描述
Primary Objective
- Proof of concept: To evaluate the efficacy of alendronate in preventing pelvic insufficiency fractures (PIFs) in cervical cancer patients treated with chemo-radiotherapy over the short and long term. This objective will assess both the immediate and sustained effects of the drug on bone integrity through periodic bone mineral density measurements and clinical assessment of fracture incidence.
Secondary Objectives
- To assess the safety and tolerability of alendronate: This will involve monitoring and documenting any acute and chronic side effects associated with alendronate use in this patient population, including but not limited to gastrointestinal issues, renal function impairment, and osteonecrosis of the jaw.
- To document and analyze changes in quality of life: Using validated quality of life instruments, this objective will track changes in patient-reported outcomes, focusing on aspects such as pain levels, physical function, and overall well-being. This will help determine if the intervention not only prevents fractures but also contributes positively to the patients' quality of life during and after treatment.
- To explore correlations between patient-specific factors and treatment efficacy: This objective aims to understand how variables such as age, cancer stage, previous treatment history, and baseline bone health might influence the effectiveness of alendronate in preventing PIFs and enhancing bone mineral density.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age: Patients must be 18 years of age or older.
- •Diagnosis:Patients diagnosed with non-metastatic cervical cancer stages IB2 to IVA, as per the FIGO staging system.
- •Treatment Plan: Patients scheduled to undergo definitive chemo-radiotherapy or adjuvant chemo-radiotherapy post-surgery.
- •Bone Health: No history of osteoporosis or previous treatment with bisphosphonates or other bone-modifying agents.
- •Pain Assessment: Patients experiencing bone pain or at risk of developing pelvic insufficiency fractures, despite current standard of care.
- •Recent Imaging: Patients must have undergone recent imaging (CT, PET, or MRI) within the last 3 months to confirm the absence of bone metastases.
- •Compliance: Patients must be able to comply with the study protocol and follow-up schedule. Psychological, familial, sociological, or geographical conditions that could hamper compliance need to be evaluated and discussed before trial registration.
- •Consent: Patients must provide written informed consent before participating in the study
排除标准
- •Age: Patients under 18 years of age.
- •Performance Status: Patients with an ECOG Performance Status of 2, 3 or
- •Bone Metastases: Presence of bone metastases.
- •Contraindications to Alendronate: Known contraindications to alendronate, such as esophageal disorders, inability to sit or stand upright for at least 30 minutes, severe renal impairment (creatinine clearance <35 mL/min), or hypersensitivity to any component of the product.
- •Concurrent Treatments: Patients receiving other concurrent treatment with bisphosphonates, denosumab, or other bone-modifying agents.
- •Special Populations: Pregnant or breastfeeding women, prisoners, and patients with major psychiatric illnesses that could interfere with adherence to study requirements.
- •Previous Treatment: Patients who have previously received radiotherapy to the pelvic region.
研究组 & 干预措施
Patients with Cancer of the Cervix Treated with Chemo-Radiotherapy
Experimental
Age: Patients must be 18 years of age or older.
- Diagnosis:Patients diagnosed with non-metastatic cervical cancer stages IB2 to IVA, as per the FIGO staging system.
- Treatment Plan: Patients scheduled to undergo definitive chemo-radiotherapy or adjuvant chemo-radiotherapy post-surgery.
- Bone Health: No history of osteoporosis or previous treatment with bisphosphonates or other bone-modifying agents.
- Pain Assessment: Patients experiencing bone pain or at risk of developing pelvic insufficiency fractures, despite current standard of care.
- Recent Imaging: Patients must have undergone recent imaging (CT, PET, or MRI) within the last 3 months to confirm the absence of bone metastases.
- Compliance: Patients must be able to comply with the study protocol and follow-up schedule. Psychological, familial, sociological, or geographical conditions that could hamper compliance need to be evaluated and discussed before trial registration.
- Consent: Patients must provide written informed co
干预措施: Alendronate 70mg weekly (Drug)
结局指标
主要结局
Pain
时间窗: Pre -treatment, 5,12 and 24 months post-initiation of therapy
Use of the numeral rating scale for pain
Quality of life
时间窗: Pre -treatment and 5,12 and 24 months post-initiation of therapy
Use of QLQ-C30 scale
次要结局
- Bone Mineral Density(Pre-treatment, 1 year and 2 years post-treatment)
- Blood tests for markers of bone turnover(Pre-treatment)
研究者
Dr. Itay GoorAryeh
Head of the Pain Clinic
Sheba Medical Center
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