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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, osteopenia, post-menopausal, zoledronic acid

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ. of Alabama/Division of Clinical Immunology and Rheumatology
  • Radiant Research
  • Denver Arthritis Clinic
  • Florida Medical Research Institute
  • Northwestern Center for Clinical Research
  • The Center for Rheumatology and Bone Research
  • Midwest Arthritis Center
  • St. John's Medical Research
  • Deaconess Billings Clinic Research Division
  • UMDNJ-Robert Wood Johnson Medical School
  • Helen Hayes Hospital - Regional Bone Clinic
  • Private Practice
  • The Arthritis Clinic of Jackson
  • Radiant Research
  • Univ. of North Texas Health Science Center at Fort Worth
  • St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education
  • Women's Health Center
  • Valley Medical Associates

Outcomes

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

Full Information

First Posted
January 3, 2005
Last Updated
April 26, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00100555
Brief Title
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
Official Title
A Study of the Clinical Safety, Tolerability, and Efficacy of Zoledronic Acid Compared to an Oral Bisphosphonate
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, osteopenia, post-menopausal, zoledronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To assess the frequency, intensity, and "bothersomeness" of dyspepsia, as measured by the Nepean Dyspepsia Index - Short Form, Symptom Checklist
Title
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Univ. of Alabama/Division of Clinical Immunology and Rheumatology
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Radiant Research
City
San DIego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Florida Medical Research Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Midwest Arthritis Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048-1634
Country
United States
Facility Name
St. John's Medical Research
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Deaconess Billings Clinic Research Division
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Helen Hayes Hospital - Regional Bone Clinic
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States
Facility Name
Private Practice
City
Mayfield Village
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Name
The Arthritis Clinic of Jackson
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Univ. of North Texas Health Science Center at Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
St. Luke's Episcopal Hospital Ctr for Ortho. Res. and Education
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Women's Health Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Valley Medical Associates
City
Lewisburg
State/Province
West Virginia
ZIP/Postal Code
24901
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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