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Maintaining Bone Strength in Men With Prostate Cancer

NCT ID: NCT00391950

Last Updated: 2009-11-23

Study Results

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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The purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year, in increasing bone strength in men with prostate cancer. All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months. Both patient and doctor will know which treatment a patient is receiving.

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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Prostate cancer Cancer treatment induced bone loss (CTIBL) Androgen deprivation therapy (ADT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zoledronic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Histologically confirmed diagnosis of carcinoma of the prostate

* 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 with normal BMD at trial entry

* 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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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United Kingdom

Other Identifiers

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CZOL446GGB12

Identifier Type: -

Identifier Source: org_study_id