A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00100555
First received: January 3, 2005
Last updated: April 26, 2012
Last verified: April 2012
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Purpose
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.
| 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 of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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:
- 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
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2004 |
| Study Completion Date: | June 2005 |
| Primary Completion Date: | June 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:
- Postmenopausal women between 45 and 79 years of age
- Must be osteopenic/osteoporotic
Exclusion Criteria:
- Any women of child-bearing potential
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100555
Locations
| United States, Alabama | |
| Univ. of Alabama/Division of Clinical Immunology and Rheumatology | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Radiant Research | |
| San DIego, California, United States, 92108 | |
| United States, Colorado | |
| Denver Arthritis Clinic | |
| Denver, Colorado, United States, 80230 | |
| United States, Florida | |
| Florida Medical Research Institute | |
| Gainesville, Florida, United States, 32605 | |
| United States, Illinois | |
| Northwestern Center for Clinical Research | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| The Center for Rheumatology and Bone Research | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Michigan | |
| Midwest Arthritis Center | |
| Kalamazoo, Michigan, United States, 49048-1634 | |
| United States, Missouri | |
| St. John's Medical Research | |
| Springfield, Missouri, United States, 65807 | |
| United States, Montana | |
| Deaconess Billings Clinic Research Division | |
| Billings, Montana, United States, 59101 | |
| United States, New Jersey | |
| UMDNJ-Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, New York | |
| Helen Hayes Hospital - Regional Bone Clinic | |
| West Haverstraw, New York, United States, 10993 | |
| United States, Ohio | |
| Private Practice | |
| Mayfield Village, Ohio, United States, 44143 | |
| United States, Tennessee | |
| The Arthritis Clinic of Jackson | |
| Jackson, Tennessee, United States, 38305 | |
| United States, Texas | |
| Radiant Research | |
| Dallas, Texas, United States, 75235 | |
| Univ. of North Texas Health Science Center at Fort Worth | |
| Fort Worth, Texas, United States, 76107 | |
| St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Women's Health Center | |
| Salt Lake City, Utah, United States, 84117 | |
| United States, West Virginia | |
| Valley Medical Associates | |
| Lewisburg, West Virginia, United States, 24901 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00100555 History of Changes |
| Other Study ID Numbers: | CZOL446H2315 |
| Study First Received: | January 3, 2005 |
| 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 May 23, 2013