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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097825
• Other study ID #: CZOL446M2308
• Status: Completed
• Phase: Phase 3
• First received: November 30, 2004
• Last updated: April 26, 2012
• Start date: April 2004
• Est. completion date: August 2007

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Zoledronic Acid

Locations

Country	Name	City	State
Australia	Repatriation General Hospital	Daw Park	South Australia
Australia	Keogh Institute for Medical Research	Nedlands	Western Australia
Australia	Garvan Institute of Medical Research	Sydney	New South Wales
Canada	QEII HealthSciences Center	Halifax	Nova Scotia
Canada	Charlton Medical Building	Hamilton	Ontario
Canada	Centre De Recherche Clinique De Laval	Laval	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Groupe de Recherche en Rhumatologie et Maladies Osseuses	Sainte-Foy	Quebec
Canada	Saskatoon Osteoporosis Center	Saskatoon	Saskatchewan
Canada	Clinical Research Center	Vancouver	British Columbia
United States	New Mexico Clinical Research and Osteoporosis Center	Albuquerque	New Mexico
United States	St. Joseph Hospital	Bangor	Maine
United States	Northwestern Center for Clinical Research	Chicago	Illinois
United States	UC Bone Health and Osteoporosis Center	Cincinnati	Ohio
United States	Mercy Arthritis and Osteoporosis Center	Des Moines	Iowa
United States	United Osteoporosis Center	Gainesville	Georgia
United States	Osteoporosis and Clinical Trials Center	Hagerstown	Maryland
United States	Colorado Center for Bone Research	Lakewood	Colorado
United States	Hampton Roads Center for Clinical Research	Norfolk	Virginia
United States	Oregon Health Sciences University	Portland	Oregon
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Radiant Research	Stuart	Florida
United States	Catalina Pointe Clinical Research Inc.	Tucson	Arizona
United States	Diablo Clinical Research	Walnut Creek	California
United States	Helen Hayes Hospital	West Haverstraw	New York
United States	Radiant Research	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline