Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Novartis Pharmaceuticals220 enrolled

Overview

The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Osteoporosis

Interventions

zoledronic acidDRUG

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Post-menopausal women between 45 and 79 years of age * Must be osteopenic/osteoporotic * Treatment with oral bisphosphonate for at least 1 year Exclusion Criteria: * Any woman of child bearing potential * Treatment with other bone active agents Other protocol-defined inclusion/exclusion criteria may apply.

Locations (13)

The Permanente Medical Group

Santa Rosa, California, United States

Colorado Center for Bone Research

Lakewood, Colorado, United States

Florida Medical Research Institute

Gainsville, Florida, United States

Outcomes

Primary Outcomes

To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations

Secondary Outcomes

To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations

To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients

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

Data from ClinicalTrials.gov

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