Description:

ODM derived from http://clinicaltrials.gov/show/NCT00332709

Link:

http://clinicaltrials.gov/show/NCT00332709

Keywords:
Versions (2) ▾
  1. 12/11/13
  2. 4/14/14
Uploaded on:

April 14, 2014

DOI:
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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00332709 Osteoporosis. Postmenopausal

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Age 18 Years and older
Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)
ECOG performance status finding
Patients without severe osteoporosis at study entry
No evidence of relapse at the time of randomization
Adequate function of bone marrow, kidney, and liver
Exclusion Criteria
Estrogen- and progesterone-receptor status negative or unknown
Completion of adjuvant tamoxifen therapy more than 6 months prior to study start
Inflammatory Breast Carcinoma, Mastitis carcinomatosa
Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
Recent (within 6 weeks) or planned dental or jaw surgery
History of diseases with influence on bone metabolism such as Paget's disease and primary overactive parathyroid
Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones, Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect the skeleton (such as calcitonin, mithramycin, or gallium nitrate)
Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer of the cervix. Patients with previous other cancer(s) must have been disease-free for at least 5 years.
Patients currently receiving oral bisphosphonates must discontinue these at least 3 weeks prior to study start.