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The Safety and Efficacy of Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss
This study is currently recruiting participants.
Verified by Novartis, June 2008
Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00375505
  Purpose

This study examines the safety and efficacy of zoledronic acid 4 mg., given every 3 months over 24 months (infusion at month 0, 3, 6, 9, 12, 15, 18 and 21) in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment


Condition Intervention Phase
Breast Cancer
Drug: Zoledronic acid
Phase III

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Minerals
Drug Information available for: Zoledronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Zoledronic Acid in the Prevention of Cancer Therapy Induced Bone Loss

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in bone mineral density (BMD) measured by DXA at lumbar spine (L2-L4) between baseline and 24 months

Secondary Outcome Measures:
  • Bone mineral density (BMD) measured by DXA at dual hips and os calcis after 24 months
  • Bone mineral density (BMD) measured by QUS at os calcis and phalanges after 24 months

Estimated Enrollment: 70
Study Start Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Female patients with histologically confirmed incident invasive breast cancer (T1-4) with positive hormone receptor status (ER and/or PgR positive) and no evidence of regional lymph node metastasis (N0) or distant metastasis (M0)
  • Patient has undergone complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
  • Patient is premenopausal at diagnosis of breast cancer (spontaneous and regular menses with premenopausal estradiol levels (>10 ng/dL)
  • Patient receives adjuvant standard chemoendocrine or endocrine therapy
  • Bone density at study entry > -2.5 T-Score

Exclusion Criteria

  • History of treatment or disease affecting bone metabolism (e.g., Paget's disease, primary hyperparathyroidism), prior treatment with bisphosphonates or treatments for osteoporosis in addition to calcium and vitamin D
  • Abnormal renal function
  • Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures, recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
  • Pregnancy or lactation
  • Women of childbearing potential not applying a medically recognized form of contraception (i.e., oral contraceptives or implants, IUD, vaginal diaphragm or sponge, or condom with spermicide)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375505

Contacts
Contact: Novartis 41 61 324 1111

Locations
Germany
Recruiting
Marburg, Germany
Contact: Novartis     41 61 324 1111        
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Responsible Party: Novartis ( External Affairs )
Study ID Numbers: CZOL446GDE21
Study First Received: September 11, 2006
Last Updated: June 30, 2008
ClinicalTrials.gov Identifier: NCT00375505  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Breast Cancer
Premenopausal
Bone mineral density
Cancer therapy induced bone loss
zoledronic acid

Study placed in the following topic categories:
Diphosphonates
Zoledronic acid
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009