Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid
A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
1 other identifier
interventional
220
2 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2004
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 30, 2004
CompletedFirst Posted
Study publicly available on registry
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 27, 2012
April 1, 2012
1.6 years
November 30, 2004
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Post-menopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
- Treatment with oral bisphosphonate for at least 1 year
You may not qualify if:
- Any woman of child bearing potential
- Treatment with other bone active agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
The Permanente Medical Group
Santa Rosa, California, 95403, United States
Colorado Center for Bone Research
Lakewood, Colorado, 80227, United States
Florida Medical Research Institute
Gainsville, Florida, 32605, United States
Radiant Research
Stuart, Florida, 34996, United States
University of Kansas School of Medicine/ Division of Endocrinology
Kansas City, Kansas, 66160, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Arthritis Center of Nebraska
Lincoln, Nebraska, 68516, United States
Creighton University Osteoporosis Research Center
Omaha, Nebraska, 68131, United States
Oregon Osteoporosis Center
Portland, Oregon, 97213, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Radiant Research
Wyomissing, Pennsylvania, 19610, United States
Puget Sound Osteoporosis Center
Seattle, Washington, 98144, United States
Novartis
Nuremberg, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2004
First Posted
December 1, 2004
Study Start
May 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 27, 2012
Record last verified: 2012-04