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MULTICENTRE, RANDOMIZED, OPEN-LABEL, TWO-ARM PARALLEL GROUPS, ACTIVE CONTROLLED STUDY DESIGN TO DEMONSTRATE EFFICACY AND TOLERABILITY OF CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK VS CLODRONATE 100 MG/3,3ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK IN A 1-YEAR TREATMENT PERIOD OF WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS

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Trial Profile

MULTICENTRE, RANDOMIZED, OPEN-LABEL, TWO-ARM PARALLEL GROUPS, ACTIVE CONTROLLED STUDY DESIGN TO DEMONSTRATE EFFICACY AND TOLERABILITY OF CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK VS CLODRONATE 100 MG/3,3ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK IN A 1-YEAR TREATMENT PERIOD OF WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2017

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At a glance

  • Drugs Clodronic acid (Primary) ; Lidocaine (Primary)
  • Indications Injection site pain; Postmenopausal osteoporosis
  • Focus Biomarker; Registrational; Therapeutic Use

    • Most Recent Events

    • 29 Mar 2015 Results (PP population n=219) presented at the 2015 World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases.
    • 04 Mar 2013 Status changed from active, no longer recruiting to completed as reported by European Clinical Trials Database.
    • 06 Jun 2012 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.

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