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.
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.
Performance Status: Patients with an ECOG Performance Status of 2, 3 or 4.
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.
Dr. Itay GoorAryeh
Lead sponsor
Sheba Medical Center
Sponsor institution