The purpose of the study is to investigate a new therapy for treating bone pain that results from cancer that has spread to the bones. The study compares treatment with ibandronic acid against treatment with another drug, zoledronic acid (a drug similar to ibandronic acid) to determine which drug is more successful in decreasing bone pain.

Condition	Treatment or Intervention	Phase
Pain Bone Neoplasms Neoplasm Metastasis	Drug: ibandronic acid	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of cancer
• Test results (X-ray, CT Scan or MRI) showing that the cancer has spread to the bone
• Moderate to severe pain that corresponds to the area where the cancer has spread to the bone and the bone pain is being treated by a doctor with pain killers
• No changes to the type of cancer chemotherapy for the past 6 weeks before the study starts
• Adequate kidney function
• Normal calcium levels in the blood

Exclusion Criteria:

• Patients with a high risk of fracturing a bone
• Patients with cancer that has spread to the brain
• Patients with Paget’s disease of bone
• Patients with untreated esophagitis or gastric ulcers (patients may be eligible for study BO18040)
• Patients who are receiving other investigational therapies
• Patients who are pregnant or lactating

Please reference Study ID Number: PDO-BO18039      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

California
      Rancho Mirage,  California,  92270,  United States
      Santa Monica,  California,  90404,  United States
      Greenbrae,  California,  94904,  United States
Georgia
      Tucker,  Georgia,  30084,  United States
      Macon,  Georgia,  31201,  United States
Idaho
      Coeur D Alene,  Idaho,  83814,  United States
Minnesota
      St. Louis Park,  Minnesota,  55416,  United States
Missouri
      St. Louis,  Missouri,  63141,  United States
North Carolina
      Durham,  North Carolina,  27710,  United States
Oregon
      Portland,  Oregon,  97227,  United States
South Carolina
      Charleston,  South Carolina,  29403-5740,  United States
Tennessee
      Memphis,  Tennessee,  38120,  United States
      Collierville,  Tennessee,  38017,  United States
Texas
      Houston,  Texas,  77030,  United States
Virginia
      Chesapeake,  Virginia,  23320,  United States
Argentina
      Cordoba,  X5000BFI,  Argentina
      Bahia Blanca,  B8001HXM,  Argentina
      Santa Fe,  03000,  Argentina
      Rosario,  2000,  Argentina
      Buenos Aires,  1426,  Argentina
      Buenos Aires,  C1426BOR,  Argentina
      Buenos Aires,  C1406FWY,  Argentina
Australia
      South Brisbane,  4101,  Australia
      Woodville,  5011,  Australia
Canada, Alberta
      Edmonton,  Alberta,  T6G 1Z2,  Canada
Canada, Ontario
      London,  Ontario,  N6A 4L6,  Canada
Canada, Quebec
      Montreal,  Quebec,  H2L 4M1,  Canada
Chile
      Santiago,  Chile
      VINA DEL MAR,  Chile
Germany
      Dessau,  06846,  Germany
      Koeln,  54290,  Germany
      Hamburg,  22143,  Germany
Greece
      THESSALONIKI,  57 010,  Greece
      Athens,  115 22,  Greece
      KALYFTAKI KIFISSIA,  Greece
Guatemala
      GUATEMALA,  Guatemala
Hungary
      Budapest,  1122,  Hungary
      Budapest,  1529,  Hungary
      Deszk,  6772,  Hungary
      Szeged,  6720,  Hungary
Italy
      Rozzano,  20089,  Italy
      Torino,  Italy
Mexico
      Mexico City,  14050,  Mexico
      La Paz,  23040,  Mexico
      Mexicali,  21100,  Mexico
Panama
      ANCÓN,  Panama
Poland
      Poznan,  61-878,  Poland
      Poznan,  60-569,  Poland
Puerto Rico
      San Juan,  00935,  Puerto Rico
Russian Federation
      Moscow,  Russian Federation
      Moscow,  115478,  Russian Federation
      Moscow,  117837,  Russian Federation
      Moscow,  125284,  Russian Federation
      St Petersburg,  189646,  Russian Federation
      St Petersburg,  197022,  Russian Federation
      Obninsk,  249020,  Russian Federation
      Kazan,  420029,  Russian Federation
Switzerland
      CHUR,  7000,  Switzerland
United Kingdom
      KERSEWELL,  ML118LF,  United Kingdom
      Manchester,  M20 4BX,  United Kingdom
      Sutton,  SM2 5PT,  United Kingdom
      Bracknell,  RG12 1HX,  United Kingdom

Study ID Numbers:  BO18039
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  December 10, 2004
ClinicalTrials.gov Identifier:  NCT00099177
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08