A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00100555
First received: January 3, 2005
Last updated: April 26, 2012
Last verified: April 2012
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014