Clinical trial · Interventional
Zoledronate in Treating Patients With Cervical Intraepithelial Neoplasia 2/3 or 3
An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual was insufficient to meet study endpoints
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing, or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow to cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer from forming. PURPOSE: This randomized is studying how well zoledronate works in treating patients with cervical intraepithelial neoplasia 2/3 or 3.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo (Saline) | Other | — | UNRESOLVED |
| Zoledronate | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zoledronate
- description
- 100 cc of saline with 4 mg of zoledronate intravenous (IV), over 20 minutes, for 3 doses one week apart Treatment repeats every 21 days (one course) for up to 3 courses. In week 8, patients undergo surgical resection comprising loop excision or cone biopsy. After completion of study treatment, patients are followed at week 10 by telephone.
- interventionNames
- Drug: Zoledronate
- type
- PLACEBO_COMPARATOR
- label
- Saline
- description
- 100 cc of saline IV, over 20 minutes, for 3 doses one week apart Treatment repeats every 21 days (one course) for up to 3 courses. In week 8, patients undergo surgical resection comprising loop excision or cone biopsy. After completion of study treatment, patients are followed at week 10 by telephone.
- interventionNames
- Other: Placebo (Saline)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy confirmed cervical intraepithelial neoplasia (CIN) 2/3 or 3 * Planning loop excision or cone biopsy * Diagnosis within 2 months prior to study entry * Standard histological grading according to Richart * Visible lesion by colposcopy * No unsatisfactory colposcopy or lesions extending into the endocervical canal that cannot be visualized entirely by colposcopy * No suspicion of invasive cervical cancer by cytology, histology or colposcopy * No cytologic evidence of glandular atypia or dysplasia PATIENT CHARACTERISTICS: * Creatinine normal * Screening laboratory values within normal range (e.g., complete blood count, liver function tests, renal panel, and electrolytes) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to read and speak English or Spanish * No known hypersensitivity to bisphosphonates * Not immunocompromised * No known HIV positivity * No aspirin-sensitive asthma due to association of bisphosphonates with bronchoconstriction * No unexplained abnormal vaginal bleeding PRIOR CONCURRENT THERAPY: * No concurrent loop diuretics, aminoglycosides, other nephrotoxic drugs, immunosuppressive drugs, or other investigational agents
References
Publications (0)
Data not yet available