Alendronate to Reduce Pelvic Insufficiency Fractures in Cervical Cancer Patients Undergoing Chemo… (NCT07245381) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Alendronate to Reduce Pelvic Insufficiency Fractures in Cervical Cancer Patients Undergoing Chemoradiation
65 participantsStarted 2025-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 compon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain
Timeframe: Pre -treatment, 5,12 and 24 months post-initiation of therapy
2
Quality of life
Timeframe: Pre -treatment and 5,12 and 24 months post-initiation of therapy