Preventive Effects of Zoledronic Acid on Bone Metastasis in Patients With Stage IIIB and IV Lung Cancer

Tang-Du Hospital

Status and phase: Unknown; Phase 3

Conditions: Lung Cancer

Treatments: Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02622607

ZOL

Details and patient eligibility

About

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 .

Full description

Bone metastases are common in patients with advanced lung cancer and can have devastating consequences. which can lead to pain, decreased mobility and skeletal complications .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 SREs from malignant bone disease. Clinical trials also confirm that bisphosphonates, and zoledronic acid 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 .

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

ZOL

Experimental group

Description:

Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 months for 12 months.

Treatment:

Drug: Zoledronic acid

Control

No Intervention group

Description:

No investigational treatment