Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
300 participants
INTERVENTIONAL
2006-10-31
Brief Summary
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After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study. All participants will stop receiving the drug after 1 year and will be seen back in the clinic, annually for another 2 years for follow-up.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Zoledronic acid
Eligibility Criteria
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Inclusion Criteria
* No distant metastases
* Patients must be candidates for androgen deprivation therapy (ADT)
* Patient with a baseline BMD T-score at or below -1 standard deviations in the lumbar spine (L2-L4) are eligible
Exclusion Criteria
* Patients who received any prior bisphosphonate therapy in the past 12 months
* Treatment with anti-androgen mono- or combination therapy
* Patients who are currently receiving diethylstilbesterol (DES) or who have previously received PC-SPES
* Patients who have received prior treatment with systemic corticosteroids within the past 12 months
* Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
* Patients with any prior treatment for osteoporosis
18 Years
MALE
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: STUDY_CHAIR
Novartis
Locations
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Derby, , United Kingdom
Countries
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Other Identifiers
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CZOL446GGB12
Identifier Type: -
Identifier Source: org_study_id
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