A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Bone Pain in Patients With Breast Cancer and Skeletal Metastases

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502736

Enrollment

Registered

2007-07-18

Start date

2008-01-31

Completion date

2009-03-31

Last updated

2014-01-22

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 single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.

Interventions

DRUGibandronate [Bondronat]

6mg iv on days 1-3

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 patients, \>=18 years of age; * breast cancer; * bone metastases; * moderate to severe pain; * adequate renal function.

Exclusion criteria

* bisphosphonate treatment within 3 weeks of study enrollment.

Design outcomes

Primary

Measure	Time frame
Pain and analgesic consumption	Days 1, 7 and 14

Secondary

Measure	Time frame
AEs and laboratory parameters	Days 1, 4 and 7
Serum creatinine	Days 1, 4 and 7
Karnofsky index	Day 7

Countries

Turkey (Türkiye)

Outcome results

None listed

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