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Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC

NCT01062503 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2015-04-27

No results posted yet for this study

Summary

Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.

Conditions

Interventions

DRUG

Zoledronic acid

ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Ian F Tannock, MD, PhD · University Health Network, Toronto

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01062503 on ClinicalTrials.gov