A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

Last updated: August 14, 2017
Sponsor: Hoffmann-La Roche
Overall Status: Terminated

Phase

3

Condition

Neoplasms

Neoplasm Metastasis

Pain

Treatment

N/A

Clinical Study ID

NCT00099177
BO18039
  • Ages > 18
  • All Genders

Study Summary

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients with malignant bone disease;

  • patients with moderate to severe pain.

Exclusion

Exclusion Criteria:

  • patients who have received a bisphosphonate within 3 weeks from the signing ofinformed consent;

  • patients receiving concurrent investigational therapy, or who have receivedinvestigational therapy within 30 days of the first scheduled day of dosing;

  • untreated esophagitis or gastric ulcers;

  • recent or pre-scheduled radiotherapy to bone;

  • patients who are pregnant or breast-feeding.

Study Design

Total Participants: 96
Study Start date:
August 01, 2005
Estimated Completion Date:
December 31, 2007

Connect with a study center

  • Bahia Blanca, B8001HXM
    Argentina

    Site Not Available

  • Buenos Aires, 1426
    Argentina

    Site Not Available

  • Rosario, 2000
    Argentina

    Site Not Available

  • Santa Fe, 03000
    Argentina

    Site Not Available

  • Adelaide, 5011
    Australia

    Site Not Available

  • Brisbane, 4101
    Australia

    Site Not Available

  • Santiago,
    Chile

    Site Not Available

  • Vina Del Mar,
    Chile

    Site Not Available

  • Hamburg, 22143
    Germany

    Site Not Available

  • Kalyftaki Kifissia,
    Greece

    Site Not Available

  • Thessaloniki, 57010
    Greece

    Site Not Available

  • Guatemala City,
    Guatemala

    Site Not Available

  • Budapest, 1122
    Hungary

    Site Not Available

  • Deszk, 6772
    Hungary

    Site Not Available

  • Szeged, 6720
    Hungary

    Site Not Available

  • Rozzano, 20089
    Italy

    Site Not Available

  • Torino, 10126
    Italy

    Site Not Available

  • La Paz, 23040
    Mexico

    Site Not Available

  • Mexicali, 21100
    Mexico

    Site Not Available

  • Mexico City, 14050
    Mexico

    Site Not Available

  • Monterrey, 64320
    Mexico

    Site Not Available

  • Panama City, 83-0669
    Panama

    Site Not Available

  • Poznan, 60-569
    Poland

    Site Not Available

  • San Juan, 00935
    Puerto Rico

    Site Not Available

  • Kazan, 420029
    Russian Federation

    Site Not Available

  • Moscow, 117837
    Russian Federation

    Site Not Available

  • Obninsk, 249020
    Russian Federation

    Site Not Available

  • St Petersburg, 197022
    Russian Federation

    Site Not Available

  • St Gallen, 9007
    Switzerland

    Site Not Available

  • Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Miami, Florida 33136
    United States

    Site Not Available

  • Macon, Georgia 31201
    United States

    Site Not Available

  • Houston, Texas 77030
    United States

    Site Not Available

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