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

NCT00099203 | Terminated Phase 3

• 1 other identifier: BO18040
• Study Type: interventional
• Target: 163
• Locations: 18 countries
• Sites: 72

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.

Conditions

Pain; Bone Neoplasm; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• Pain, as measured by Brief Pain Inventory and analgesic use

  Week 24

Secondary Outcomes (4)

• Performance score and QoL measures

  Week 24

• AEs and laboratory parameters

  Throughout study

• Opioid side effects

  Throughout study

• Skeletal-related events

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Drug: ibandronate [Bondronat]

2

ACTIVE COMPARATOR

Drug: zoledronic acid

Interventions

ibandronate [Bondronat] DRUG

6mg iv on days 1-3, and every 3-4 weeks

1

zoledronic acid DRUG

4mg iv on day 1 and every 3-4 weeks

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with malignant bone disease;
• patients with moderate to severe pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (72)

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Birmingham, Alabama, 35205, United States

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Sedona, Arizona, 86336, United States

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Ocoee, Florida, 34761, United States

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Macon, Georgia, 31201, United States

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Galesburg, Illinois, 61401, United States

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Indianapolis, Indiana, 46227, United States

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Kansas City, Missouri, 64131, United States

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Henderson, Nevada, 89052, United States

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Reno, Nevada, 89502, United States

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Albany, New York, 12208, United States

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Oklahoma City, Oklahoma, 73120, United States

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Eugene, Oregon, 97401-8122, United States

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Nashville, Tennessee, 37209, United States

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Abilene, Texas, 79606-5208, United States

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Arlington, Texas, 76014, United States

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Beaumont, Texas, 77702-1449, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76177, United States

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Fredericksburg, Texas, 78624, United States

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Longview, Texas, 75601, United States

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Round Rock, Texas, 78681, United States

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Norfolk, Virginia, 23502, United States

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Seattle, Washington, 98104, United States

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Spokane, Washington, 99218, United States

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Vancouver, Washington, 98684, United States

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Buenos Aires, C1280AEB, Argentina

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Buenos Aires, C1406FWY, Argentina

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Buenos Aires, C1408INH, Argentina

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La Plata, 1900, Argentina

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Lanús, B1824DLR, Argentina

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Mendoza, 5500, Argentina

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St Leonards, 2065, Australia

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Waratah, 2298, Australia

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Brussels, 1000, Belgium

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Turnhout, 2300, Belgium

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Wilrijk, 2610, Belgium

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Greenfield Park, Quebec, J4V 2H1, Canada

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Santiago, Chile

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Lyon, 69373, France

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Nice, 06189, France

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Paris, 75248, France

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Dessau, 06846, Germany

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Duisburg, 47166, Germany

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Heidelberg, 69120, Germany

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Trier, 54290, Germany

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Guatemala City, 01010, Guatemala

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Guatemala City, 01015, Guatemala

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Guatemala City, Guatemala

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Budapest, 1125, Hungary

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Győr, 9002, Hungary

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Napoli, 80131, Italy

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Chihuahua City, 31000, Mexico

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Mexico City, 03100, Mexico

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Mérida, 97500, Mexico

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Panama City, Panama

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Lodz, 93-510, Poland

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Olsztyn, 10-228, Poland

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Otwock, 05-400, Poland

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Ponce, 00733-1324, Puerto Rico

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San Juan, 00921-3201, Puerto Rico

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Kazan', 420029, Russia

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Moscow, 115478, Russia

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Moscow, 117837, Russia

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Moscow, 125284, Russia

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Moscow, Russia

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Obninsk, 249020, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Baden, 5404, Switzerland

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Exeter, EX2 5DW, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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MeSH Terms

Conditions

Pain; Bone Neoplasms; Neoplasm Metastasis

Interventions

Ibandronic Acid; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplastic Processes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 10, 2004
• First Posted: December 10, 2004
• Study Start: July 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

RU (8); GB (2); PA (1); FR (3); DE (4); AR (6); PL (3); HU (2); PR (2); CL (1); AU (2); US (26); BE (3); CH (1); GU (3); ME (3); IT (1); CA (1)