A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss
NCT ID: NCT00333229
Last Updated: 2014-11-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
11 participants
INTERVENTIONAL
2006-03-31
2013-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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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.
Zoledronic Acid
4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
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.
Placebo
Matching Placebo
Interventions
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Zoledronic Acid
4 mg zoledronic acid in 5 mL concentrate solution. Plastic vials.
Placebo
Matching Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmeceuticals
Locations
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Novartis Investigative Site
Marburg, , Germany
Countries
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References
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Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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2004-002831-14
Identifier Type: -
Identifier Source: secondary_id
CZOL446GDE13
Identifier Type: -
Identifier Source: org_study_id