Clinical trial NCT00099203: A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Bone Neoplasm
Neoplasm Metastasis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-12-10
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Pain, as measured by Brief Pain Inventory and analgesic use
timeFrame: Week 24
Secondary outcomes:
measure: Performance score and QoL measures
timeFrame: Week 24
measure: AEs and laboratory parameters
timeFrame: Throughout study
measure: Opioid side effects
timeFrame: Throughout study
measure: Skeletal-related events
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Sedona
country: United States
state: Arizona
city: Ocoee
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Galesburg
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Reno
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Arlington
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Fredericksburg
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Round Rock
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Vancouver
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: La Plata
country: Argentina
city: Lanus
country: Argentina
city: Mendoza
country: Argentina
city: St. Leonards
country: Australia
city: Waratah
country: Australia
city: Bruxelles
country: Belgium
city: Turnhout
country: Belgium
city: Wilrijk
country: Belgium
city: Greenfield Park
country: Canada
state: Quebec
city: Santiago
country: Chile
city: Lyon
country: France
city: Nice
country: France
city: Paris
country: France
city: Dessau
country: Germany
city: Duisburg
country: Germany
city: Heidelberg
country: Germany
city: Trier
country: Germany
city: Guatemala City
country: Guatemala
city: Guatemala City
country: Guatemala
city: Guatemala City
country: Guatemala
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Napoli
country: Italy
city: Chihuahua
country: Mexico
city: Merida
country: Mexico
city: Mexico City
country: Mexico
city: Panama City
country: Panama
city: Lodz
country: Poland
city: Olsztyn
country: Poland
city: Otwock
country: Poland
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Baden
country: Switzerland
city: Exeter
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: