A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

Novartis Pharmaceuticals120 enrolled

Overview

The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Osteoporosis

Interventions

zoledronic acidDRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Postmenopausal women between 45 and 79 years of age * Must be osteopenic/osteoporotic Exclusion Criteria: * Any women of child-bearing potential Other protocol-defined inclusion/exclusion criteria may apply.

Locations (18)

Univ. of Alabama/Division of Clinical Immunology and Rheumatology

Birmingham, Alabama, United States

Radiant Research

San Diego, California, United States

Outcomes

Primary Outcomes

Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women

Secondary Outcomes

To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women

To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist

To assess patient preferences for annual i.v. therapy compared to weekly oral therapy

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.