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

Dr. Itay GoorAryeh

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Cervix Cancer

Treatments: Drug: Alendronate 70mg weekly

Study type: Interventional

Funder types: Other

Identifiers

NCT07245381

1509-24-SMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: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

Exclusion Criteria:Age: Patients under 18 years of age.

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Patients with Cancer of the Cervix Treated with Chemo-Radiotherapy

Experimental group

Description:

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

Treatment:

Drug: Alendronate 70mg weekly