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

Pain; Bone Neoplasms; Neoplasm Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553707
• Other study ID #: ML20268
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2015
• Last updated: September 16, 2015
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Neoplasms
• Neoplasm Metastasis
• Pain; Bone Neoplasms; Neoplasm Metastasis

Intervention

Drug:
• Ibandronate
Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with >=25% reduction in mean pain		up to Day 6	No
Primary	Percentage of participants with =<35% increase in mean analgesic consumption		up to Days 7	No
Secondary	Change from Baseline in average pain score		Baseline (Days 0), 5, and 7	No
Secondary	Analgesic consumption		up to Day 7	No
Secondary	Pain response		up to Day 7	No
Secondary	Time to pain response		up to Day 7	No