Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Osteoporosis Clinical Trial

Official title:

A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097812
• Other study ID #: CZOL446H2313
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2004
• Last updated: April 26, 2012
• Start date: May 2004
• Est. completion date: December 2005

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• zoledronic acid

Locations

Country	Name	City	State
Germany	Novartis	Nuernberg
United States	Florida Medical Research Institute	Gainsville	Florida
United States	University of Kansas School of Medicine/ Division of Endocrinology	Kansas City	Kansas
United States	Colorado Center for Bone Research	Lakewood	Colorado
United States	Arthritis Center of Nebraska	Lincoln	Nebraska
United States	Creighton University Osteoporosis Research Center	Omaha	Nebraska
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Osteoporosis Center	Portland	Oregon
United States	The Permanente Medical Group	Santa Rosa	California
United States	Puget Sound Osteoporosis Center	Seattle	Washington
United States	Radiant Research	Stuart	Florida
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Radiant Research	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
Secondary	To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
Secondary	To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire