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

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ClinicalTrials.gov Identifier: NCT02553707
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain; Bone Neoplasms; Neoplasm Metastasis Drug: Ibandronate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Arms and Interventions
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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 Name: Bondronat


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553707


Locations
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Hungary
Budapest, Hungary, 1031
Budapest, Hungary, 1082
Budapest, Hungary, 1106
Budapest, Hungary, 1122
Budapest, Hungary, 1135
Budapest, Hungary, 1145
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02553707    
Other Study ID Numbers: ML20268
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
 Bone Diseases
Musculoskeletal Diseases
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs