Comparative Incidence of Skeletal-Related Events in Patients with Metastatic Bone Disease: A Study of Short- versus Long-Interval Zoledronic Acid Administration, A Randomized, Open-label, Non-inferiority trial

Comparative outcomes of Short vs. Long intervals of Zoledronic Acid Injection in patient with Metastatic Bone Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250610004

Enrollment

Registered

2025-06-10

Start date

2025-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

None listed

Interventions

shorter regimen : Zoledronic acid 4 mg IV drip in 30 min for every 4-6 weeks , longer regimen : Zoledronic acid 4 mg IV drip in 30 min for every 10-12 weeks

Active Comparator Drug,Experimental Drug

4 weeks Zoledronic acid ,12 weeks Zoledronic acid

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age at diagnosis >18 2. Patient diagnosed with metastatic bone disease

Exclusion criteria

Exclusion criteria: 1. Patient with history of receiving any Bone modifying agents with in 3 months prior to the date of entry 2. Patient with history of radiotherapy treatment at the site of metastasis 3. Creatinine clearance below 30 ml/min 4. Hypersensitive to Zoledronic acid 5. Active dental condition 6. Patient with brain metastasis

Design outcomes

Primary

Measure	Time frame
Skeletal related events 12 months after end of the intervention incidence of SREs	—

Secondary

Measure	Time frame
side effect from Zoledronic acid, pain, Mirel score 12 months after end of the intervention incidence of side effect, Brief pain score, Mirel's score	—

Countries

Thailand

Contacts

Public ContactNatwara Pansrimangkorn

Lerdsin Hospital

liewetc@gmail.com023539800

Outcome results