Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00097812
First received: November 30, 2004
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 220
Study Start Date: May 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years to 79 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097812

Locations
United States, California
The Permanente Medical Group
Santa Rosa, California, United States, 95403
United States, Colorado
Colorado Center for Bone Research
Lakewood, Colorado, United States, 80227
United States, Florida
Florida Medical Research Institute
Gainsville, Florida, United States, 32605
Radiant Research
Stuart, Florida, United States, 34996
United States, Kansas
University of Kansas School of Medicine/ Division of Endocrinology
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01610
United States, Nebraska
Arthritis Center of Nebraska
Lincoln, Nebraska, United States, 68516
Creighton University Osteoporosis Research Center
Omaha, Nebraska, United States, 68131
United States, Oregon
Oregon Osteoporosis Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Radiant Research
Wyomissing, Pennsylvania, United States, 19610
United States, Washington
Puget Sound Osteoporosis Center
Seattle, Washington, United States, 98144
Germany
Novartis
Nuernberg, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00097812     History of Changes
Other Study ID Numbers: CZOL446H2313
Study First Received: November 30, 2004
Last Updated: April 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
osteoporosis, osteopenia, post-menopausal, zoledronic acid

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014