Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis

Randomized phase II study of zoledronate administration schedule comparing every 4 weeks versus every 8 weeks for metastatic lung cancer with bone metastasis - Zoledronate administration schedule P2 study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009369

Enrollment

210

Registered

2012-11-20

Start date

2012-11-21

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

Primary lung cancer

Interventions

International guidelines recommend treatment with bisphosphonates (including zoledronate) in cancer patients with bone metastasis. Standard treatment schedule is 4mg every 4 weeks. We adopted the sche

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Lung cancer patients with radiologically-proven osteolytic bone metastasis 2)Age >= 20 years 3)PS: 0 to 3 4)Estimated CCr: >= 30ml/min 5)Modified serum Ca: 8-11.5 mg/dl 6)Life expectancy of more than 4 months 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with a history of intravenous bisphosphonate therapy 2)Uncontrolled co-morbidities and/or infectious diseases 3)Women who are pregnant, have a desire to bear children or in lactation 4)Recent (within 4 weeks) tooth extraction due to dental infection 5)Planned dental or jaw surgery (e.g., extraction, implants) 6)Any other current malignancy or malignancy diagnosed within the past five years. 7)Patients deemed unacceptable for inclusion to the study.

Design outcomes

Primary

Measure	Time frame
Time to first skeletal related events (SREs), Proportion of patients experiencing SREs, Types of SREs	—

Secondary

Measure	Time frame
Proportion of patients experiencing SREs (first 6 months), Bone marker levels (NTX), Bone pain, Use of analgesics, Safety, Overall survival	—

Countries

Japan

Contacts

Public ContactShiro Fujita M.D.

Institute of Biomedical Research and Innovation Division of Integrated Oncology

sfujita@fbri.org0783045200

Outcome results

None listed

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