Skip to main content
OpenTrials
Completed

NCT Number: NCT02553707

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Budapest, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibandronate

Drug

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

Other names: Bondronat

Primary outcomes

  1. Percentage of participants with >=25% reduction in mean pain

    Time frame: up to Day 6

  2. Percentage of participants with =<35% increase in mean analgesic consumption

    Time frame: up to Days 7

Secondary outcomes

  1. Change from Baseline in average pain score

    Time frame: Baseline (Days 0), 5, and 7

  2. Analgesic consumption

    Time frame: up to Day 7

  3. Pain response

    Time frame: up to Day 7

  4. Time to pain response

    Time frame: up to Day 7

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 17, 2015
Registry last updated
Sep 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.