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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Bone Neoplasms; Neoplasm Metastasis
• Intervention / Treatment: Drug: Ibandronate

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
  • Budapest, Hungary, 1135
  • Budapest, Hungary, 1145
  • Budapest, Hungary, 1082
  • Budapest, Hungary, 1106
  • Budapest, Hungary, 1031
  • Gyor, Hungary, 9002
  • Gyula, Hungary, 5700
  • Kecskemet, Hungary, 6000
  • Nyíregyháza, Hungary, 4400
  • Szeged, Hungary, 6720
  • Szekesfehervar, Hungary, 8000
  • Szombathely, Hungary, 9700
  • Veszprem, Hungary, 8200
  • Zalaegerszeg, Hungary, 8900

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibandronate; Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.	Drug: Ibandronate; Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.; Other Names: Bondronat

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): September 17, 2015
• Last Update Submitted That Met QC Criteria: September 16, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Physiological Effects of Drugs; Bone Density Conservation Agents; Ibandronic Acid
• Other Study ID Numbers: ML20268