A phase II trial of evaluating the benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity.

A phase II trial of evaluating the benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity. - Benefit of zoledronic acid in non-small cell lung cancer patients with bone metastases.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005088

Enrollment

Registered

2011-02-15

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer patients with bone metastases and elevated marker of osteoclast activity

Interventions

Zoledronic acid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed NSCLC. Patients who have radiologically apparent bone metastasis. Patients aged 20 years or older. ECOG performance status of 0-2. Sufficient function of main organ filled the following criteria before two weeks from enrollment: Neu >= 1,500/ mm3 Hb >= 9.0g/dl Plt >= 100,000/ mm3 T-Bil <= 1.5mg/dl GOT <= 100IU/ml GPT <= 100IU/ml Cre <= 1.5mg/dl. Urinary NTx> 64nmol/mmol Cr. Written informed consent.

Exclusion criteria

Exclusion criteria: Patients who need radiotherapy or surgery immediately against bone metastases. Prior treatment with Sr-89. Prior bisphosphonates used for cancer. Patients with symptomatic brain metastasis. Severe odontopathy. Interstitial pneumonia on chest x-ray. Patients with active concomitant malignancy. Uncontrolled heart disease, hepatic disease, diabetes mellitus, bleeding. EGFR (+) and planned for EGFR-TKI treatment.

Design outcomes

Primary

Measure	Time frame
Proportion of patients who developed SRE.	—

Secondary

Measure	Time frame
1.Time to first SRE 2.Safety 3.Progression free survival 4.Overall survival 5.Response rate 6.Rate of change of bone marker 7.Rate of change of pain score	—

Countries

Japan

Contacts

Public ContactTaishi Harada

Kyushu University, Graduate School of Medical Sciences Research Institute for Diseases of the Chest

harada-t@kokyu.med.kyushu-u.ac.jp092-642-5378

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026