Conditions: Non-Small-Cell Lung Cancer
Keywords: Non-Small-Cell Lung Cancer Bisphosphonates Zoledronic acid Bone metastases Prevention of bone metastases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 437
Healthy volunteers: no

Brief summary:
30-40% of patients with lung cancer will develop bone metastases during the course of their disease, which can lead to pain, decreased mobility and skeletal complications. This study will investigate the effect of zoledronic acid on preventing or delaying the development of bone metastases and the impact on disease progression/survival in patients with stage IIIA and IIIB Non-small Cell Lung Cancer (NSCLC).

Detailed description:

Arms:
arm 1: Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment. arm 2: No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.

Interventions: intervention 1: Zoledronic acid 4 mg
Intervention descriptions: intervention 1: Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride or 5% glucose solution).

Protocol document: