Clinical trial · Interventional
Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Bisphosphonates are inhibitors of osteoclast-mediated bone resorption. The current indications for bisphosphonates include the treatment of metabolic disorders of bone metabolism (e.g., osteoporosis and Paget's disease), the treatment of hypercalcaemia of malignancy (HCM), and the prevention of skeletal-related events(SREs）from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid（ZOL) in particular, can prevent bone loss from cancer treatment.There is also emerging evidence that the benefits of bisphosphonate therapy in the oncology setting are more extensive. This study will evaluate whether the addition of ZOL 4 mg every 3 months for up to 1 years in patients with stage IIIB/IV lung cancer could reduce the rate of bone metastases ,improve progression-free survival (PFS) and overall survival(OS), and delay time to bone metastases .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ZOL
- description
- Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months.
- interventionNames
- Drug: Zoledronic acid
- type
- NO_INTERVENTION
- label
- Control
- description
- No investigational treatment
Primary outcomes (1)
- measure
- Percentage of Participants With Bone Metastases at 12 Months
- timeFrame
- Months 12
- description
- Percentage of participants developing at least 1 bone metastasis, whether or not symptomatic. Bone scans were scheduled at screening and at 6-monthly intervals after study entry, or when symptoms suggested the presence of bone metastases. Positive bone scans required confirmation by x-ray, magnetic resonance imaging (MRI), or computed tomography (CT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 70 years of age, male or female 2. histologically or cytologically confirmed stage IIIB or IV lung cancer at diagnosis 3. no evidence of bone metastatic lesions was radiographically confirmed by bone scintigraphy 4. life expectancy of ≥6 months 5. adequate renal, hematologic, and hepatic 6. Eastern Cooperative Oncology Group(ECOG) performance status≤2 7. All patients provided written informed consent Exclusion Criteria: 1. Treatment with other bisphosphonates 2. Presence of brain metastases 3. Be allergic to ZOL 4. attending other unlisted drug clinical trials,currently.
References
Publications (0)
Data not yet available