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A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00333229
First received: May 31, 2006
Last updated: January 10, 2013
Last verified: January 2013
History of Changes
  Purpose

Breast cancer and osteoporosis are two of the most frequent diseases in women. Estrogen may be associated with bone loss and the risk of breast cancer because of its potent effects on the mitotic activity of breast epithelium and on bone turnover.

This study is will assess the safety and efficacy of Zoledronic acid 4 mg, given every 3 months over 24 months, in improving bone mineral density in premenopausal women with hormone receptor negative breast cancer and adjuvant chemotherapeutic treatment compared to placebo.

This study is not recruiting patients in the United States.


Condition Intervention Phase
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
 Drug: Zoledronic Acid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment

Resource links provided by NLM:

U.S. FDA Resources

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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density (BMD) measured by DXA at dual hips and os calcis after 24 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Bone mineral density (BMD) measured by QUS at os calcis and phalanges after 24 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Course of biochemical markers of bone turn over (FSH, estradiol (E2), osteocalcin, PINP, procollagene-I-peptid, deoxypyridinoline in serum) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Pathologic fractures during 24 month [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Development of metastases as assessed by X-ray, CT, or MRI during 24 months and during 60 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: March 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ZOL446 3 monthly Drug: Zoledronic Acid
Placebo Comparator: Placebo Drug: Zoledronic Acid

  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 no evidence of regional lymph node metastasis (N0) or distant metastasis (M0) and after complete primary tumor resection and axillary lymph node dissection less than 90 days before start of study drug treatment.
  • Hormone receptor status is negative
  • Patient is premenopausal (spontaneous and regular menses with premenopausal estradiol levels (>10ng/dL)
  • Patient receives adjuvant standard chemotherapy with approved cytotoxic chemotherapeutic drugs (e.g. AC 4-6 cycles) (prior neoadjuvant CT is allowed)
  • Bone density at study entry > -2.5 T-Score

Exclusion Criteria:

  • Prior treatment with bisphosphonates and estrogens or treatments for osteoporosis in addition to calcium and vitamin D
  • Severe physical or psychological concomitant diseases and other known concurrent, severe medical disorder jeopardizing the life of the patient in the immediate future (e.g., myocardial infarction in previous six months, angina pectoris despite treatment, uncontrolled severe arterial hypertension, progressive cardiac or respiratory failure)
  • Known hypersensitivity to bisphosphonates
  • 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 and recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333229

Locations
Germany
Novartis Investigative Site
Marburg, Germany, 35043
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00333229     History of Changes
Other Study ID Numbers: CZOL446GDE13, 2004-002831-14
Study First Received: May 31, 2006
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013