A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

Open-Label Study to Establish the Short Term Efficacy of Intravenous Loading-Doses of Bondronat 6 mg in Patients With Breast Cancer and Skeletal Metastases Experiencing Moderate to Severe Pain, Within 7 Days After Initiation of Treatment

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02553707

Enrollment

182

Registered

2015-09-17

Start date

2006-07-31

Completion date

2008-12-31

Last updated

2015-09-17

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

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Brief summary

This study will assess the short term efficacy of ibandronate (6 mg intravenous \[IV\]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

Interventions

DRUGIbandronate

Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Female participants greater than or equal to (\>=) 18 years of age * Breast cancer with bone metastases * Pain score of \>=4 on Worst Pain scale of Brief Pain Inventory (BPI) * Stable analgesic regimen.

Exclusion criteria

* Participants who have received a bisphosphonate within 3 weeks of start of trial * Radiotherapy to bone within 4 weeks of enrolment * Hypersensitivity to ibandronate * Central nervous system (CNS) or meningeal metastases

Design outcomes

Primary

Measure	Time frame
Percentage of participants with >=25% reduction in mean pain	up to Day 6
Percentage of participants with =<35% increase in mean analgesic consumption	up to Days 7

Secondary

Measure	Time frame
Change from Baseline in average pain score	Baseline (Days 0), 5, and 7
Analgesic consumption	up to Day 7
Pain response	up to Day 7
Time to pain response	up to Day 7

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026