A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
- Conditions
- Osteoporosis
- Registration Number
- NCT00100555
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
- Postmenopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
- Any women of child-bearing potential
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (17)
Univ. of Alabama/Division of Clinical Immunology and Rheumatology
🇺🇸Birmingham, Alabama, United States
Radiant Research
🇺🇸Dallas, Texas, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
Northwestern Center for Clinical Research
🇺🇸Chicago, Illinois, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Midwest Arthritis Center
🇺🇸Kalamazoo, Michigan, United States
St. John's Medical Research
🇺🇸Springfield, Missouri, United States
Deaconess Billings Clinic Research Division
🇺🇸Billings, Montana, United States
UMDNJ-Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Scroll for more (7 remaining)Univ. of Alabama/Division of Clinical Immunology and Rheumatology🇺🇸Birmingham, Alabama, United States