Clinical trial NCT00099177: A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
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
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: 96
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 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.


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 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: Miami
country: United States
state: Florida
city: Macon
country: United States
state: Georgia
city: Houston
country: United States
state: Texas
city: Bahia Blanca
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Rosario
country: Argentina
city: Santa Fe
country: Argentina
city: Adelaide
country: Australia
city: Brisbane
country: Australia
city: Santiago
country: Chile
city: Vina Del Mar
country: Chile
city: Hamburg
country: Germany
city: Kalyftaki Kifissia
country: Greece
city: Thessaloniki
country: Greece
city: Guatemala City
country: Guatemala
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Deszk
country: Hungary
city: Szeged
country: Hungary
city: Rozzano
country: Italy
city: Torino
country: Italy
city: La Paz
country: Mexico
city: Mexicali
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Panama City
country: Panama
city: Poznan
country: Poland
city: Poznan
country: Poland
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: St Gallen
country: Switzerland
city: Manchester
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: