Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00381368

Enrollment

Registered

2006-09-27

Start date

2006-10-31

Completion date

Unknown

Last updated

2006-12-04

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

Conditions

Breast Cancer

Keywords

breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases

Brief summary

The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skeletal metastases.

Detailed description

Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the patients often need additional treatments that may relieve their symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a significant decrease in pain scores, both after loading dose and after long-term treatment. In this study the safety and efficacy of an intravenous loading dose of three times 6 mg ibandronate during three consecutive days in breast cancer patients with painful skeletal metastases will be studied.

Interventions

DRUGIbandronic acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Breast cancer with presence of bone metastases * Pain score over 4 on the VAS

Exclusion criteria

* Patients with pathological fractures or medulla compression or neuropathic pain * Patients with infection or corticosteroid treatment * Pregnant or lactating patients

Design outcomes

Primary

Measure	Time frame
Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28	—
Analgesic consumption during the same period will additionally be assessed	—

Secondary

Measure	Time frame
World Health Organization (WHO) performance status	—
Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28	—
Safety: serum cystatin C and serum creatinine, and reporting of adverse events	—

Countries

Finland

Contacts

Primary ContactOuti Paija, MD, PhD

outi.paija@tyks.fi+358-2-3130000

Backup ContactTiina Saarto, MD, PhD

tiina.saarto@hus.fi

Outcome results

None listed

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