Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Phase 3

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00097812
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2004-11-30
• Study First Submitted QC: 2004-11-30
• Study First Posted: 2004-12-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-26
• Last Update Posted: 2012-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (12)

Arthritis Center of Nebraska; 🇺🇸 Lincoln, Nebraska, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Novartis; 🇩🇪 Nuernberg, Germany

Colorado Center for Bone Research; 🇺🇸 Lakewood, Colorado, United States

The Permanente Medical Group; 🇺🇸 Santa Rosa, California, United States

University of Kansas School of Medicine/ Division of Endocrinology; 🇺🇸 Kansas City, Kansas, United States

Florida Medical Research Institute; 🇺🇸 Gainsville, Florida, United States

Clinical Pharmacology Study Group; 🇺🇸 Worcester, Massachusetts, United States

Creighton University Osteoporosis Research Center; 🇺🇸 Omaha, Nebraska, United States

Oregon Osteoporosis Center; 🇺🇸 Portland, Oregon, United States

Puget Sound Osteoporosis Center; 🇺🇸 Seattle, Washington, United States

Radiant Research; 🇺🇸 Wyomissing, Pennsylvania, United States