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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00099203
Other study ID # BO18040
Secondary ID
Status Terminated
Phase Phase 3
First received December 10, 2004
Last updated August 14, 2017
Start date July 2005
Est. completion date December 2007

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 163
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 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.

Study Design


Intervention

Drug:
ibandronate [Bondronat]
6mg iv on days 1-3, and every 3-4 weeks
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,  Belgium,  Canada,  Chile,  France,  Germany,  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
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