Alendronate to Reduce Pelvic Insufficiency Fractures in Cervical Cancer Patients Undergoing Chemoradiation

NCT ID: NCT07245381

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Cervix Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Cancer of the Cervix Treated with Chemo-Radiotherapy

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

Group Type: EXPERIMENTAL

Alendronate 70mg weekly

Intervention Type: DRUG

the Use of Alendronate to Reduce the Risk of Developing Pelvic Insufficiency Fractures in Patients with Cancer of the Cervix Treated with Chemo-Radiotherapy

Interventions

Alendronate 70mg weekly

the Use of Alendronate to Reduce the Risk of Developing Pelvic Insufficiency Fractures in Patients with Cancer of the Cervix Treated with Chemo-Radiotherapy

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Itay GoorAryeh

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Itay GoorAryeh

Head of the Pain Clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Akram Saad, Dr

Role: CONTACT

Akram.Saad@sheba.health.gov.il

+972 548130386

Other Identifiers

1509-24-SMC

Identifier Type: -

Identifier Source: org_study_id