Spots Global Cancer Trial Database for Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
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Trial Identification
Brief Title: Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
Official Title: An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
Study ID: NCT00171340
Study Description
Brief Summary: Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
Detailed Description:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Novartis Investigative Site, Buenos Aires, , Argentina
Novartis Investigative Site, Rosario Santa Fe, , Argentina
Novartis Investigative Site, New South Wales, , Australia
Novartis Investigative Site, Perth, , Australia
Novartis Investigative Site, South Australia, , Australia
Novartis Investigative Site, Victoria, , Australia
Novartis Investigative Site, Bonheiden, , Belgium
Novartis Investigative Site, Brasschaat, , Belgium
Novartis Investigative Site, Brussels, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Wilrijk, , Belgium
Novartis Investigative Site, Porto Alegre, , Brazil
Novartis Investigative Site, Sao Paulo, , Brazil
Novartis Investigative Site, Santiago, , Chile
Novartis Investigative Site, Beijing, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Medellin, , Colombia
Novartis Investigative Site, Nemocnice, , Czech Republic
Novartis Investigative Site, Cairo, , Egypt
Novartis Investigative Site, Pori, , Finland
Novartis Investigative Site, Turku, , Finland
Novartis Investigative Site, Bordeaux Cedex, , France
Novartis Investigative Site, Le Havre, , France
Novartis Investigative Site, Montpellier Cedex, , France
Novartis Investigative Site, Poitiers Cedex, , France
Novartis Investigative Site, St. Cloud, , France
Novartis Investigative Site, Augsberg, , Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Ebersberg, , Germany
Novartis Investigative Site, Frankfurt, , Germany
Novartis Investigative Site, Halberstadt, , Germany
Novartis Investigative Site, Hamburg, , Germany
Novartis Investigative Site, Hoyerswerda, , Germany
Novartis Investigative Site, Kassel, , Germany
Novartis Investigative Site, Kiel, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Munich, , Germany
Novartis Investigative Site, Neunkirchen, , Germany
Novartis Investigative Site, Rostock, , Germany
Novartis Investigative Site, Stadthagen, , Germany
Novartis Investigative Site, Stendal, , Germany
Novartis Investigative Site, Trier, , Germany
Novartis Investigative Site, Tubingen, , Germany
Novartis Investigative Site, Wiesbaden, , Germany
Novartis Investigative Site, Guatemala City, , Guatemala
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Ancona, , Italy
Novartis Investigative Site, Aviano, , Italy
Novartis Investigative Site, Bergamo, , Italy
Novartis Investigative Site, Catanzaro, , Italy
Novartis Investigative Site, Firenze, , Italy
Novartis Investigative Site, Genova, , Italy
Novartis Investigative Site, Meldola, , Italy
Novartis Investigative Site, Modena, , Italy
Novartis Investigative Site, Orbassano Torino, , Italy
Novartis Investigative Site, Perugia, , Italy
Novartis Investigative Site, Torino, , Italy
Novartis Investigative Site, Varese, , Italy
Novartis Investigative Site, Gyeonggi, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Distrito Federal, , Mexico
Novartis Investigative Site, Almere, , Netherlands
Novartis Investigative Site, Arnhem, , Netherlands
Novartis Investigative Site, Den Haag, , Netherlands
Novartis Investigative Site, Ede, , Netherlands
Novartis Investigative Site, Eindhoven, , Netherlands
Novartis Investigative Site, Hoogeveen, , Netherlands
Novartis Investigative Site, Leiden, , Netherlands
Novartis Investigative Site, Nijmegen, , Netherlands
Novartis Investigative Site, Utrecht, , Netherlands
Novartis Investigative Site, Hamilton, , New Zealand
Novartis Investigative Site, Wellington, , New Zealand
Novartis Investigative Site, Jesus Maria, , Peru
Novartis Investigative Site, La Victoria, , Peru
Novartis Investigative Site, Surquillo, , Peru
Novartis Investigative Site, Cebu City, , Philippines
Novartis Investigative Site, Quezon City, , Philippines
Novartis Investigative Site, Coimbra, , Portugal
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Cordoba, , Spain
Novartis Investigative Site, Gea, , Spain
Novartis Investigative Site, Ibanez, , Spain
Novartis Investigative Site, La Maso, , Spain
Novartis Investigative Site, Villaroel, , Spain
Novartis Investigative Site, Bern, , Switzerland
Novartis Investigative Site, Locarno, , Switzerland
Novartis Investigative Site, Lugano, , Switzerland
Novartis Investigative Site, Chang Hwa, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Ratchathew, Khonkaen, , Thailand
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, Essex, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, New Castle Upon Tyne, , United Kingdom
Novartis Investigative Site, Nottingham, , United Kingdom
Novartis Investigative Site, Plymouth, , United Kingdom
Novartis Investigative Site, Sheffield, , United Kingdom
Novartis Investigative Site, Swansea, , United Kingdom
Novartis Investigative Site, Caracas, , Venezuela
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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