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

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00097825
• Collaborator: (none)
• Enrollment: 288
• Locations: 26
• Duration (Months): 40
• Patients Per Site: 11.1
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Zoledronic Acid	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 []

2. 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 []

3. To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catalina Pointe Clinical Research Inc.	Tucson	Arizona	United States	85704
2	Diablo Clinical Research	Walnut Creek	California	United States	94598
3	Colorado Center for Bone Research	Lakewood	Colorado	United States	80227
4	Radiant Research	Stuart	Florida	United States	34996
5	United Osteoporosis Center	Gainesville	Georgia	United States	30501
6	Northwestern Center for Clinical Research	Chicago	Illinois	United States	60611
7	Mercy Arthritis and Osteoporosis Center	Des Moines	Iowa	United States	50322
8	St. Joseph Hospital	Bangor	Maine	United States	04401
9	Osteoporosis and Clinical Trials Center	Hagerstown	Maryland	United States	21740
10	New Mexico Clinical Research and Osteoporosis Center	Albuquerque	New Mexico	United States	87106
11	Helen Hayes Hospital	West Haverstraw	New York	United States	10993
12	UC Bone Health and Osteoporosis Center	Cincinnati	Ohio	United States	45219
13	Oregon Health Sciences University	Portland	Oregon	United States	97239
14	Radiant Research	Wyomissing	Pennsylvania	United States	19610
15	Hampton Roads Center for Clinical Research	Norfolk	Virginia	United States	23502
16	McGuire VA Medical Center	Richmond	Virginia	United States	23249
17	Garvan Institute of Medical Research	Sydney	New South Wales	Australia	2010
18	Repatriation General Hospital	Daw Park	South Australia	Australia	5041
19	Keogh Institute for Medical Research	Nedlands	Western Australia	Australia	6009
20	Clinical Research Center	Vancouver	British Columbia	Canada	V5Z 2N6
21	QEII HealthSciences Center	Halifax	Nova Scotia	Canada	B3H 2Y9
22	Charlton Medical Building	Hamilton	Ontario	Canada	L8N 1Y2
23	Centre De Recherche Clinique De Laval	Laval	Quebec	Canada	H7T 2P5
24	Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1
25	Groupe de Recherche en Rhumatologie et Maladies Osseuses	Sainte-Foy	Quebec	Canada	G1V 3M7
26	Saskatoon Osteoporosis Center	Saskatoon	Saskatchewan	Canada	S7K 0H6

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• For information regarding US facilities, click this hyperlink.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00097825
• Other Study ID Numbers: CZOL446M2308
• First Posted: Dec 1, 2004
• Last Update Posted: Apr 27, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by , ,: Male Osteoporosis
• Additional relevant MeSH terms: Osteoporosis; Zoledronic Acid

Study Results

No Results Posted as of Apr 27, 2012