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

This study has been terminated.
(Due to rare patient population, planned number of patients could not be recruited in a reasonable timeframe. Recruitment was stopped prematurely.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333229
First Posted: June 2, 2006
Last Update Posted: November 25, 2014
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
May 31, 2006
June 2, 2006
November 17, 2014
November 25, 2014
November 25, 2014
March 2006
December 2013   (Final data collection date for primary outcome measure)
Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months. [ Time Frame: 24 months ]
Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.
Complete list of historical versions of study NCT00333229 on ClinicalTrials.gov Archive Site
  • Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months [ Time Frame: 2 years ]
  • Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum) [ Time Frame: 2 years ]
  • Pathologic Fractures During 24 Month [ Time Frame: 2 years ]
  • Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months [ Time Frame: 2 years ]
  • 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
  • Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)
  • Pathologic Fractures During 24 Month
  • Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months
Not Provided
Not Provided
 
A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
Influence of Zoledronic Acid on Bone Mineral Density and Bone Ultrasonometry in Premenopausal Women With Hormone Receptor Negative Breast Cancer and Adjuvant Chemotherapeutic Treatment

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
  • Drug: Zoledronic Acid
    4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
  • Drug: Placebo
    Matching Placebo
  • 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.
    Intervention: Drug: Zoledronic Acid
  • 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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
December 2013
December 2013   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00333229
CZOL446GDE13
2004-002831-14
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP