A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
1 other identifier
interventional
120
1 country
18
Brief Summary
The purpose of this trial is to study the clinical safety, tolerability, and efficacy of zoledronic acid compared to an oral bisphosphonate in postmenopausal women with osteoporosis.
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 Jun 2004
Shorter than P25 for phase_3
18 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
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 3, 2005
CompletedFirst Posted
Study publicly available on registry
January 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedApril 27, 2012
April 1, 2012
1 year
January 3, 2005
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the rapidity of onset of action on bone turnover by comparing the percent change from baseline in urine N-telopeptide (NTx) in post-menopausal women
Secondary Outcomes (3)
To assess the effect on markers of bone turnover by comparing the percent change from baseline in serum C-telopeptide (CTx) and urine NTx in post-menopausal women
To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
You may not qualify if:
- Any women of child-bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Univ. of Alabama/Division of Clinical Immunology and Rheumatology
Birmingham, Alabama, 35294, United States
Radiant Research
San Diego, California, 92108, United States
Denver Arthritis Clinic
Denver, Colorado, 80230, United States
Florida Medical Research Institute
Gainesville, Florida, 32605, United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Midwest Arthritis Center
Kalamazoo, Michigan, 49048-1634, United States
St. John's Medical Research
Springfield, Missouri, 65807, United States
Deaconess Billings Clinic Research Division
Billings, Montana, 59101, United States
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Helen Hayes Hospital - Regional Bone Clinic
West Haverstraw, New York, 10993, United States
Private Practice
Mayfield Village, Ohio, 44143, United States
The Arthritis Clinic of Jackson
Jackson, Tennessee, 38305, United States
Radiant Research
Dallas, Texas, 75235, United States
Univ. of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, 76107, United States
St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education
Houston, Texas, 77030, United States
Women's Health Center
Salt Lake City, Utah, 84117, United States
Valley Medical Associates
Lewisburg, West Virginia, 24901, United States
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
Study Record Dates
First Submitted
January 3, 2005
First Posted
January 4, 2005
Study Start
June 1, 2004
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
April 27, 2012
Record last verified: 2012-04