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Clinical Trials/ISRCTN38477744
ISRCTN38477744
Completed
Not Applicable

A double-blind placebo-controlled randomised trial of oral sodium clodronate for metastatic prostate adenocarcinoma

Medical Research Council (MRC) (UK)0 sites311 target enrollmentApril 6, 2000
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ConditionsProstate cancerCancerMalignant neoplasm of prostate

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate cancer
Sponsor
Medical Research Council (MRC) (UK)
Enrollment
311
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 6, 2000
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Medical Research Council (MRC) (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Proven histological diagnosis of prostate cancer or Prostate\-Specific Antigen (PSA) more than 100 mg/l
  • •2\. Metastatic bone disease demonstrated on bone scan or skeletal radiographs (Stage M1b)
  • •3\. Patients commencing or clinically responding to initial hormone treatment with orchidectomy, Luteinising Hormone Releasing Hormone (LHRH) analogues, cyproterone acetate, flutamide or complete androgen blockade but with no previous hormone treatment
  • •4\. Normocalcaemic (serum calcium within the normal range of the centre)
  • •5\. WHO performance status of 0, 1 or 2
  • •6\. No concomitant or previous use of other bisphosphonates
  • •7\. Serum creatinine less than twice upper limit of normal range of centre
  • •8\. No administration of any investigational drug within 12 months

Exclusion Criteria

  • •Does not meet inclusion criteria

Outcomes

Primary Outcomes

Not specified

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