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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00099177

Purpose

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.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, 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:

MedlinePlus related topics: Bone Cancer Bone Diseases Cancer

Drug Information available for: Ibandronic acid Zoledronic acid Ibandronate sodium

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Performance score and QoL measures [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Opioid side effects [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Skeletal-related events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	August 2005
Estimated Study Completion Date:	January 2007

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronate [Bondronat] 6mg iv on days 1-3, and 50mg po from day 22 to week 24
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
Genders Eligible for Study:	Both
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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099177

Show 41 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00099177 History of Changes
Other Study ID Numbers:	BO18039
Study First Received:	December 10, 2004
Last Updated:	May 20, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bone Diseases
Bone Neoplasms
Neoplasms
Neoplasm Metastasis
Musculoskeletal Diseases
Neoplasms by Site
Neoplastic Processes

Pathologic Processes
Zoledronic acid
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012