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

NCT02553707 | Completed Phase 4

• 1 other identifier: ML20268
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 15

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.

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

Ibandronate

EXPERIMENTAL

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

Drug: Ibandronate

Interventions

Ibandronate DRUG

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

Also known as: Bondronat

Ibandronate

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Unknown Facility

Budapest, 1031, Hungary

Location

Unknown Facility

Budapest, 1082, Hungary

Location

Unknown Facility

Budapest, 1106, Hungary

Location

Unknown Facility

Budapest, 1122, Hungary

Location

Unknown Facility

Budapest, 1135, Hungary

Location

Unknown Facility

Budapest, 1145, Hungary

Location

Unknown Facility

Győr, 9002, Hungary

Location

Unknown Facility

Gyula, 5700, Hungary

Location

Unknown Facility

Kecskemét, 6000, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Szeged, 6720, Hungary

Location

Unknown Facility

Székesfehérvár, 8000, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Veszprém, 8200, Hungary

Location

Unknown Facility

Zalaegerszeg, 8900, Hungary

Location

MeSH Terms

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplastic Processes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 17, 2015
• Study Start: July 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 17, 2015

Record last verified: 2015-09

Locations

HU (15)