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Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
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: Post-menopausal women between 45 and 79 years of age Must be osteopenic/osteoporotic Treatment with oral bisphosphonate for at least 1 year Exclusion Criteria: Any woman of child bearing potential Treatment with other bone active agents Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • The Permanente Medical Group
  • Colorado Center for Bone Research
  • Florida Medical Research Institute
  • Radiant Research
  • University of Kansas School of Medicine/ Division of Endocrinology
  • Clinical Pharmacology Study Group
  • Arthritis Center of Nebraska
  • Creighton University Osteoporosis Research Center
  • Oregon Osteoporosis Center
  • University of Pittsburgh
  • Radiant Research
  • Puget Sound Osteoporosis Center
  • Novartis

Outcomes

Primary Outcome Measures

To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations

Secondary Outcome Measures

To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire

Full Information

First Posted
November 30, 2004
Last Updated
April 26, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00097812
Brief Title
Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid
Official Title
A Study to Assess the Safety, Tolerability, and Efficacy of Switching Patients Currently on Oral Bisphosphonate to Zoledronic Acid
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess bone mineral density in patients switching from an oral bisphosphonate to zoledronic acid, compared to those staying on the oral bisphosphonate.

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
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Primary Outcome Measure Information:
Title
To compare % change in Lumbar Spine BMD from Baseline to Month 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic post-menopausal women populations
Secondary Outcome Measure Information:
Title
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations
Title
To demonstrate continued bone remodeling by evaluation of bone biopsies in a subset of patients
Title
To assess patient preferences for annual i.v. therapy compared to weekly oral therapy through a patient questionnaire

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: Post-menopausal women between 45 and 79 years of age Must be osteopenic/osteoporotic Treatment with oral bisphosphonate for at least 1 year Exclusion Criteria: Any woman of child bearing potential Treatment with other bone active agents Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
The Permanente Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Colorado Center for Bone Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Florida Medical Research Institute
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Radiant Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
University of Kansas School of Medicine/ Division of Endocrinology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Arthritis Center of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Creighton University Osteoporosis Research Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Oregon Osteoporosis Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Radiant Research
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Puget Sound Osteoporosis Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
Novartis
City
Nuernberg
Country
Germany

12. IPD Sharing Statement

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Switching Osteoporosis Patients Currently on Oral Bisphosphonate to Zoledronic Acid

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