Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Last updated: April 10, 2012
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Breast Cancer

Bone Density

Cancer

Treatment

N/A

Clinical Study ID

NCT00171340
CFEM345D2405
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Stage I-IIIa breast cancer

  • Postmenopausal or recently postmenopausal

  • Recent surgery for breast cancer

  • Estrogen Receptor positive and/or progesterone receptor positive hormone receptorstatus

  • No prior treatment with letrozole Other protocol-defined inclusion criteria may apply.

Exclusion

Exclusion Criteria:

  • Metastatic disease

  • Invasive bilateral disease

  • Clinical or radiological evidence of existing fracture in spine or hip

  • Prior treatment with IV bisphosphonates in the past 12 months

  • Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks ofbaseline evaluation)

  • Use of Tibolone within 6 months

  • Prior use of parathyroid hormone for more than 1 week

  • Previous or concomitant malignancy

  • Abnormal renal function

  • History of disease effecting bone metabolism Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 1065
Study Start date:
May 01, 2003
Estimated Completion Date:
February 28, 2010

Connect with a study center

  • Novartis Investigative Site

    Buenos Aires,
    Argentina

    Site Not Available

  • Novartis Investigative Site

    Rosario Santa Fe,
    Argentina

    Site Not Available

  • Novartis Investigative Site

    New South Wales,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Perth,
    Australia

    Site Not Available

  • Novartis Investigative Site

    South Australia,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Victoria,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bonheiden,
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Brasschaat,
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Brussels,
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven,
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Wilrijk,
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Porto Alegre,
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Sao Paulo,
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Santiago,
    Chile

    Site Not Available

  • Novartis Investigative Site

    Beijing,
    China

    Site Not Available

  • Novartis Investigative Site

    Shanghai,
    China

    Site Not Available

  • Novartis Investigative Site

    Medellin,
    Colombia

    Site Not Available

  • Novartis Investigative Site

    Nemocnice,
    Czech Republic

    Site Not Available

  • Novartis Investigative Site

    Cairo,
    Egypt

    Site Not Available

  • Novartis Investigative Site

    Pori,
    Finland

    Site Not Available

  • Novartis Investigative Site

    Turku,
    Finland

    Site Not Available

  • Novartis Investigative Site

    Bordeaux Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    Le Havre,
    France

    Site Not Available

  • Novartis Investigative Site

    Montpellier Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    Poitiers Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    St. Cloud,
    France

    Site Not Available

  • Novartis Investigative Site

    Augsberg,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ebersberg,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Frankfurt,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Halberstadt,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hoyerswerda,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kassel,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Kiel,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Muenchen,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Munich,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Neunkirchen,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rostock,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stadthagen,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Stendal,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Trier,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Tubingen,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Wiesbaden,
    Germany

    Site Not Available

  • Novartis Investigative Site

    Guatemala City,
    Guatemala

    Site Not Available

  • Novartis Investigative Site

    Hong Kong,
    Hong Kong

    Site Not Available

  • Novartis Investigative Site

    Ancona,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Aviano, 33081
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bergamo,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Catanzaro, 88100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Firenze, 50139
    Italy

    Site Not Available

  • Novartis Investigative Site

    Genova,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Meldola,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Modena,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano Torino,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Perugia,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Torino,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Varese,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Gyeonggi,
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Seoul, 139
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Distrito Federal,
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Almere,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Arnhem,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Den Haag,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Ede,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Eindhoven,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Hoogeveen,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Leiden,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Nijmegen,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Utrecht,
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Hamilton,
    New Zealand

    Site Not Available

  • Novartis Investigative Site

    Wellington,
    New Zealand

    Site Not Available

  • Novartis Investigative Site

    Jesus Maria,
    Peru

    Site Not Available

  • Novartis Investigative Site

    La Victoria,
    Peru

    Site Not Available

  • Novartis Investigative Site

    Surquillo,
    Peru

    Site Not Available

  • Novartis Investigative Site

    Cebu City,
    Philippines

    Site Not Available

  • Novartis Investigative Site

    Quezon City,
    Philippines

    Site Not Available

  • Novartis Investigative Site

    Coimbra,
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Barcelona,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Cordoba,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Gea,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Ibanez,
    Spain

    Site Not Available

  • Novartis Investigative Site

    La Maso,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Villaroel,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Bern,
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Locarno,
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Lugano,
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Chang Hwa, 500
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Taipei, 100
    Taiwan

    Site Not Available

  • Novartis Investigative Site

    Bangkok,
    Thailand

    Site Not Available

  • Ratchathew

    Khonkaen, 40002
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Birmingham,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Essex,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Manchester,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    New Castle Upon Tyne,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Nottingham,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Plymouth,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Sheffield,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Swansea,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Caracas,
    Venezuela

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.