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Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

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 Male Osteoporosis

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Male, 25-85 years old Exclusion Criteria: Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate) History of severe liver, kidney or eye disease Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Catalina Pointe Clinical Research Inc.
  • Diablo Clinical Research
  • Colorado Center for Bone Research
  • Radiant Research
  • United Osteoporosis Center
  • Northwestern Center for Clinical Research
  • Mercy Arthritis and Osteoporosis Center
  • St. Joseph Hospital
  • Osteoporosis and Clinical Trials Center
  • New Mexico Clinical Research and Osteoporosis Center
  • Helen Hayes Hospital
  • UC Bone Health and Osteoporosis Center
  • Oregon Health Sciences University
  • Radiant Research
  • Hampton Roads Center for Clinical Research
  • McGuire VA Medical Center
  • Garvan Institute of Medical Research
  • Repatriation General Hospital
  • Keogh Institute for Medical Research
  • Clinical Research Center
  • QEII HealthSciences Center
  • Charlton Medical Building
  • Centre De Recherche Clinique De Laval
  • Royal Victoria Hospital
  • Groupe de Recherche en Rhumatologie et Maladies Osseuses
  • Saskatoon Osteoporosis Center

Outcomes

Primary Outcome Measures

To compare % change in Lumbar Spine BMD from Baseline to Month 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations

Secondary Outcome Measures

To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline

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
NCT00097825
Brief Title
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
Official Title
Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The goal of this study is to determine the effectiveness and safety of an annual intravenous treatment of zoledronic acid for the treatment of osteoporosis in men. All patients will receive calcium and vitamin D supplements.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Male Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
288 (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 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
Secondary Outcome Measure Information:
Title
To compare % change in Lumbar Spine BMD from Baseline to Months 6 and 12 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
Title
To compare % change in BMD at the Total Hip, Femoral Neck, Trochanter and Total Body, from Baseline to Months 6, 12 and 24 in ZOL (annual i.v. infusion) vs Alendronate (weekly oral) osteoporotic male populations
Title
To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male, 25-85 years old Exclusion Criteria: Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate) History of severe liver, kidney or eye disease Other protocol-defined inclusion/exclusion criteria may apply.
Facility Information:
Facility Name
Catalina Pointe Clinical Research Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Colorado Center for Bone Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
Radiant Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
United Osteoporosis Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Mercy Arthritis and Osteoporosis Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50322
Country
United States
Facility Name
St. Joseph Hospital
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Osteoporosis and Clinical Trials Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
New Mexico Clinical Research and Osteoporosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Helen Hayes Hospital
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States
Facility Name
UC Bone Health and Osteoporosis Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Radiant Research
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Hampton Roads Center for Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Garvan Institute of Medical Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Repatriation General Hospital
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Keogh Institute for Medical Research
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Clinical Research Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2N6
Country
Canada
Facility Name
QEII HealthSciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Charlton Medical Building
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Centre De Recherche Clinique De Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Groupe de Recherche en Rhumatologie et Maladies Osseuses
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Saskatoon Osteoporosis Center
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21037195
Citation
Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.
Results Reference
derived
Links:
URL
http://www.novartisclinicaltrials.com/etrials/searchTrial.do?t=i&trialID=291&diseaseID=33
Description
For information regarding US facilities, click this hyperlink.

Learn more about this trial

Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men

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