A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

Condition(s) targeted: Pain;; Bone Neoplasms;; Neoplasm Metastasis

Intervention: ibandronate [Bondronat] (Drug); zoledronic acid (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Pain, as measured by Brief Pain Inventory and analgesic use

Secondary outcome:

Performance score and QoL measures

AEs and laboratory parameters

Opioid side effects

Skeletal-related events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

BUENOS AIRES C1280AEB, Argentina

BUENOS AIRES C1408INH, Argentina

MENDOZA 5500, Argentina

LA PLATA 1900, Argentina

LANUS B1824DLR, Argentina

BUENOS AIRES C1406FWY, Argentina

ST. LEONARDS 2065, Australia

WARATAH 2298, Australia

BRUXELLES 1000, Belgium

WILRIJK 2610, Belgium

TURNHOUT 2300, Belgium

SANTIAGO, Chile

SANTIAGO, Chile

NICE 06189, France

PARIS 75248, France

LYON 69373, France

HEIDELBERG 69120, Germany

DUISBURG 47166, Germany

TRIER 54290, Germany

DESSAU 06846, Germany

GUATEMALA CITY, Guatemala

GUATEMALA CITY 01015, Guatemala

GUATEMALA CITY 01010, Guatemala

BUDAPEST 1125, Hungary

GYOR 9002, Hungary

NAPOLI 80131, Italy

CHIHUAHUA 31000, Mexico

MERIDA 97500, Mexico

MEXICO CITY 03100, Mexico

PANAMA CITY, Panama

OLSZTYN 10-228, Poland

OTWOCK 05-400, Poland

LODZ 93-510, Poland

SAN JUAN 00921-3201, Puerto Rico

PONCE 00733-1324, Puerto Rico

MOSCOW 115478, Russian Federation

ST PETERSBURG 197022, Russian Federation

ST PETERSBURG 197758, Russian Federation

KAZAN 420029, Russian Federation

MOSCOW, Russian Federation

OBNINSK 249020, Russian Federation

MOSCOW 117837, Russian Federation

MOSCOW 125284, Russian Federation

BADEN 5404, Switzerland

EXETER EX2 5DW, United Kingdom

WOLVERHAMPTON WV10 0QP, United Kingdom

BIRMINGHAM, Alabama 35205, United States

SEDONA, Arizona 86336, United States

OCOEE, Florida 34761, United States

MACON, Georgia 31201, United States

GALESBURG, Illinois 61401, United States

INDIANAPOLIS, Indiana 46227, United States

KANSAS CITY, Missouri 64131, United States

HENDERSON, Nevada 89052, United States

RENO, Nevada 89502, United States

ALBANY, New York 12208, United States

OKLAHOMA CITY, Oklahoma 73120, United States

EUGENE, Oregon 97401-8122, United States

GREENFIELD PARK, Quebec J4V 2H1, Canada

NASHVILLE, Tennessee 37209, United States

FORT WORTH, Texas 76177, United States

ARLINGTON, Texas 76014, United States

LONGVIEW, Texas 75601, United States

ROUND ROCK, Texas 78681, United States

FREDERICKSBURG, Texas 78624, United States

DALLAS, Texas 75231, United States

BEAUMONT, Texas 77702-1449, United States

ABILENE, Texas 79606-5208, United States

DALLAS, Texas 75230, United States

NORFOLK, Virginia 23502, United States

SPOKANE, Washington 99218, United States

VANCOUVER, Washington 98684, United States

SEATTLE, Washington 98104, United States

Starting date: July 2005
Ending date: January 2007
Last updated: May 20, 2008