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A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00099203
First received: December 10, 2004
Last updated: August 23, 2016
Last verified: August 2016
  Purpose
This 2 arm study will compare the efficacy of intravenous 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 and then every 3-4 weeks) 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.

Condition Intervention Phase
Pain; Bone Neoplasms; Neoplasm Metastasis Drug: ibandronate [Bondronat] Drug: zoledronic acid Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pain, as measured by Brief Pain Inventory and analgesic use [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • Performance score and QoL measures [ Time Frame: Week 24 ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ]
  • Opioid side effects [ Time Frame: Throughout study ]
  • Skeletal-related events [ Time Frame: Throughout study ]

Enrollment: 163
Study Start Date: July 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bondronat]
6mg iv on days 1-3, and every 3-4 weeks
Active Comparator: 2 Drug: zoledronic acid
4mg iv on day 1 and every 3-4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with malignant bone disease;
  • patients with moderate to severe pain.

Exclusion Criteria:

  • patients who have received a bisphosphonate within 3 weeks from the signing of the informed consent;
  • patients receiving concurrent investigational therapy, or who have received investigational 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099203

  Show 72 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00099203     History of Changes
Other Study ID Numbers: BO18040
Study First Received: December 10, 2004
Last Updated: August 23, 2016

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Bone Diseases
Bone Neoplasms
Neoplastic Processes
Pathologic Processes
Musculoskeletal Diseases
Neoplasms by Site
Zoledronic acid
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2017