Spots Global Cancer Trial Database for A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
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Trial Identification
Brief Title: 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 ID: NCT00099177
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Miami, Florida, United States
, Macon, Georgia, United States
, Houston, Texas, United States
, Bahia Blanca, , Argentina
, Buenos Aires, , Argentina
, Buenos Aires, , Argentina
, Rosario, , Argentina
, Santa Fe, , Argentina
, Adelaide, , Australia
, Brisbane, , Australia
, Santiago, , Chile
, Vina Del Mar, , Chile
, Hamburg, , Germany
, Kalyftaki Kifissia, , Greece
, Thessaloniki, , Greece
, Guatemala City, , Guatemala
, Budapest, , Hungary
, Budapest, , Hungary
, Deszk, , Hungary
, Szeged, , Hungary
, Rozzano, , Italy
, Torino, , Italy
, La Paz, , Mexico
, Mexicali, , Mexico
, Mexico City, , Mexico
, Monterrey, , Mexico
, Panama City, , Panama
, Poznan, , Poland
, Poznan, , Poland
, San Juan, , Puerto Rico
, Kazan, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Obninsk, , Russian Federation
, St Petersburg, , Russian Federation
, St Petersburg, , Russian Federation
, St Gallen, , Switzerland
, Manchester, , United Kingdom
, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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