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 who are receiving other investigational therapies
• Patients who are pregnant or lactating

Please reference Study ID Number: PDO-BO18040      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35205,  United States
Arizona
      Tucson,  Arizona,  85715,  United States
      Sedona,  Arizona,  86336,  United States
Arkansas
      Jonesboro,  Arkansas,  72401,  United States
Florida
      Ocoee,  Florida,  34761,  United States
      New Port Richey,  Florida,  34652,  United States
      Bonita Springs,  Florida,  34135,  United States
      Port Charlotte,  Florida,  33980,  United States
Georgia
      Macon,  Georgia,  31201,  United States
Indiana
      Indianapolis,  Indiana,  46227,  United States
Missouri
      Columbia,  Missouri,  65201,  United States
      Kansas City,  Missouri,  64131,  United States
Nevada
      Henderson,  Nevada,  89052,  United States
      Reno,  Nevada,  89502,  United States
North Carolina
      Cary,  North Carolina,  27511,  United States
      Hickory,  North Carolina,  28602,  United States
Ohio
      Kettering,  Ohio,  45409,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73120,  United States
      Tulsa,  Oklahoma,  74136,  United States
Oregon
      Eugene,  Oregon,  97401-8122,  United States
Pennsylvania
      Kingston,  Pennsylvania,  18704,  United States
Texas
      Dallas,  Texas,  75204,  United States
      Dallas,  Texas,  75231-4400,  United States
      Dallas,  Texas,  75230,  United States
      Arlington,  Texas,  76014,  United States
      Richardson,  Texas,  75080,  United States
      Abilene,  Texas,  79606-5208,  United States
      Fredericksburg,  Texas,  78624,  United States
      Beaumont,  Texas,  77702-1449,  United States
      Longview,  Texas,  75601,  United States
      Fort Worth,  Texas,  76104,  United States
      Round Rock,  Texas,  78681,  United States
Virginia
      Norfolk,  Virginia,  23502,  United States
      Fairfax,  Virginia,  22031,  United States
      Chesapeake,  Virginia,  23320,  United States
Washington
      Vancouver,  Washington,  98684,  United States
      Spokane,  Washington,  99218,  United States
Argentina
      Buenos Aires,  C1408INH,  Argentina
      Buenos Aires,  C1280AEB,  Argentina
      LANUS, BUENOS AIRES,  B1824DLR,  Argentina
      La Plata,  1900,  Argentina
      Mendoza,  5500,  Argentina
Australia
      Sydney,  2065,  Australia
      Newcastle,  2298,  Australia
Belgium
      Wilrijk,  2610,  Belgium
      Brussels,  1000,  Belgium
Canada, British Columbia
      Vancouver,  British Columbia,  V5Z 4E6,  Canada
Canada, Quebec
      Greenfield Park,  Quebec,  J4V 2H1,  Canada
Chile
      Santiago,  Chile
France
      Paris,  75248,  France
      Paris,  75014,  France
      Lyon,  69373,  France
      Nice,  06189,  France
Germany
      Dessau,  06846,  Germany
      Heidelberg,  69120,  Germany
      Duisburg,  47166,  Germany
      Trier,  54290,  Germany
Greece
      Athens,  10676,  Greece
      Athens,  11521,  Greece
      Patras,  26500,  Greece
Guatemala
      GUATEMALA,  Guatemala
      Guatemala City,  01015,  Guatemala
Hungary
      Budapest,  1125,  Hungary
      Budapest,  1121,  Hungary
      Gyor,  9002,  Hungary
Italy
      Napoli,  80131,  Italy
      Milano,  Italy
Mexico
      Mexico City,  03229,  Mexico
      Merida,  97500,  Mexico
      Chihuahua,  31000,  Mexico
Panama
      Panama City,  2745,  Panama
Poland
      Lodz,  93-510,  Poland
      Olsztyn,  10-228,  Poland
      Otwock,  05-400,  Poland
Puerto Rico
      San Juan,  00921-3201,  Puerto Rico
      Ponce,  00733-1324,  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
      Baden,  5404,  Switzerland
United Kingdom
      Exeter,  EX2 DDW,  United Kingdom
      KERSEWELL,  ML118LF,  United Kingdom
      Bracknell,  RG12 1HX,  United Kingdom
      Wolverhampton,  WV10 0QP,  United Kingdom

Study ID Numbers:  BO18040
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  December 10, 2004
ClinicalTrials.gov Identifier:  NCT00099203
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08