This protocol is designed to compare the effect on bone of Zometa 4 mg every 6 months when given upfront versus delayed start ( based on a post-baseline BMD T- Score below –2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIa postmenopausal women with hormone receptor positive breast cancer who will receive Femara 2.5 mg daily as an adjuvant therapy.

Condition	Treatment or Intervention	Phase
Breast Neoplasms Osteoporosis	Drug: Zometa & Femara	Phase III

Further Study Details: 

Expected Total Enrollment:  500

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Female

Criteria

• Postmenopausal women with Stage I, II, or IIIa, ER and/or PR+ breast cancer with no clinical or radiological evidence of recurrent or metastatic disease before randomization.
• Patients must have undergone complete tumor resection and margins of the resected specimen must be microscopically free of tumor.
• In patients with tumor positive margins of the resected specimen, radiotherapy is mandatory.

Arkansas
      Highlands Oncology Group, Springdale,  Arkansas,  72764,  United States
California
      Louisiana Oncology Associates, Lafayette,  California,  70506,  United States
      Pacific Shores Medical Group, Long Beach,  California,  90813,  United States
      Redwood Regional Medical Group, Santa Rosa,  California,  95403,  United States
      Wilshire Oncology Medical Group, LaVerne,  California,  91750,  United States
      East Valley Hematology & Oncology, Burbank,  California,  91505,  United States
      Clinical Trials & Research Associates, Inc., Montebello,  California,  90640,  United States
Colorado
      Cancer and Blood Institute of the Desert, Rancho Mirage,  Colorado,  92270,  United States
Connecticut
      Eastern Connecticut Hematology/Oncology Associates, Norwich,  Connecticut,  06360,  United States
Florida
      Robert R. Carroll, MD, PA, Gainesville,  Florida,  32605,  United States
      Space Coast Medical, Titusville,  Florida,  32796,  United States
      Oncology Hematology Group of South Florida, Miami,  Florida,  33176,  United States
      Pasco Pinellas Cancer Center, New Port Richey,  Florida,  34652,  United States
      Ocala Oncology Center, Ocala,  Florida,  33479,  United States
      Bay Area Oncology, Tampa,  Florida,  33607,  United States
      FL Community Cancer Center, Brooksville,  Florida,  34613,  United States
      Cancer Research Network, Inc., Plantation,  Florida,  33324,  United States
Illinois
      Elmhurst Memorial Hospital, Elhurst,  Illinois,  United States
Kentucky
      Kentuckiana Cancer Institute, Louisville,  Kentucky,  United States
Maryland
      Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick,  Maryland,  21701,  United States
Massachusetts
      New England Hematology/Oncology Associates, Wellesley,  Massachusetts,  02481,  United States
Michigan
      Cook Research Department at Spectrum Health, Grand Rapids,  Michigan,  49503,  United States
Minnesota
      Metro Minnesota CCOP, St. Louis Park,  Minnesota,  55416,  United States
Montana
      Hematology-Oncology Centers of the Northern Rockies, PC, Billings,  Montana,  59101,  United States
Nebraska
      Methodist Cancer Center, Omaha,  Nebraska,  68114,  United States
New Jersey
      Hematology-Oncology Associates of Northern NJ, Morristown,  New Jersey,  07962,  United States
New Mexico
      New Mexico Oncology Hematology, Ltd., Albuquerque,  New Mexico,  87109,  United States
New York
      Hemoncare PC, Brooklyn,  New York,  11235,  United States
North Dakota
      Odyssey Research Services, Bismarck,  North Dakota,  58501,  United States
Ohio
      Physician Associates, Inc., Cincinnati,  Ohio,  45238,  United States
      Oncology Partners Network, Cincinnati,  Ohio,  45238,  United States
      Nashat Y. Gabrail MD Inc., Canton,  Ohio,  44718,  United States
      Dayton Clinical Oncology Program, Dayton,  Ohio,  United States
Pennsylvania
      University of Pittsburgh Cancer Institute/Magee Womens Hospital, Pittsburgh,  Pennsylvania,  15213,  United States
South Carolina
      Charleston Hematology Oncology, Charleston,  South Carolina,  29403,  United States
Tennessee
      The Sarah Cannon Cancer Center, Nashville,  Tennessee,  37203,  United States
Texas
      Center for Oncology Research & Tx. PA, Dallas,  Texas,  75230,  United States
      Cancer Specialists of South Texas, Corpus Christi,  Texas,  78412,  United States
      St. Joseph Regional Cancer Center, Bryan,  Texas,  77802,  United States
Virginia
      Northern Virginia Oncology Group, Fairfax,  Virginia,  22031,  United States
      Virginia Physicians, Inc.- Oncology, Richmond,  Virginia,  23294,  United States
Washington
      Rockwood Clinic, PS, Spokane,  Washington,  99220,  United States
      Swedish Cancer Institute, Seattle,  Washington,  United States
Puerto Rico
      VA Medical Center, San Juan,  00927,  Puerto Rico

Study ID Numbers:  CZOL446E US32
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 18, 2002
ClinicalTrials.gov Identifier:  NCT00050011
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17