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

Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00099177
• Other study ID #: BO18039
• Status: Terminated
• Phase: Phase 3
• First received: December 10, 2004
• Last updated: August 14, 2017
• Start date: August 2005
• Est. completion date: December 2007

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases
• Bone Neoplasm
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Pain

Intervention

Drug:
• ibandronate [Bondronat]
6mg iv on days 1-3, and 50mg po from day 22 to week 24
• zoledronic acid
4mg iv on day 1, and every 3-4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Chile,  Germany,  Greece,  Guatemala,  Hungary,  Italy,  Mexico,  Panama,  Poland,  Puerto Rico,  Russian Federation,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, as measured by Brief Pain Inventory and analgesic use		Week 24
Secondary	Performance score and QoL measures		Week 24
Secondary	AEs and laboratory parameters		Throughout study
Secondary	Opioid side effects		Throughout study
Secondary	Skeletal-related events		Throughout study