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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333229
Recruitment Status : Terminated (Due to rare patient population, planned number of patients could not be recruited in a reasonable timeframe. Recruitment was stopped prematurely.)
First Posted : June 2, 2006
Results First Posted : November 25, 2014
Last Update Posted : November 25, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

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 or disease Intervention/treatment Phase
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women Drug: Zoledronic Acid Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : March 2006
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Zoledronic Acid
Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Drug: Zoledronic Acid
4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.

Placebo Comparator: Placebo
Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Drug: Placebo
Matching Placebo

Primary Outcome Measures :
  1. Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months [ Time Frame: 2 years ]
  2. Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum) [ Time Frame: 2 years ]
  3. Pathologic Fractures During 24 Month [ Time Frame: 2 years ]
  4. Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00333229

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Novartis Investigative Site
Marburg, Germany, 35043
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals

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Responsible Party: Novartis Pharmaceuticals Identifier: NCT00333229    
Other Study ID Numbers: CZOL446GDE13
First Posted: June 2, 2006    Key Record Dates
Results First Posted: November 25, 2014
Last Update Posted: November 25, 2014
Last Verified: November 2014
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast Cancer
Bone Mineral density
Cancer therapy induced bone loss
zoledronic acid
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs