Clinical trial NCT00097825: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Male Osteoporosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-01
Enrollment: 288
Sex: MALE
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: 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
measure: To compare Biomarkers of bone turnover in the annual Zol i.v. and weekly alendronate populations at all study timepoints, relative to Baseline
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research Inc.
state: Arizona
city: Walnut Creek
country: United States
facility: Diablo Clinical Research
state: California
city: Lakewood
country: United States
facility: Colorado Center for Bone Research
state: Colorado
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: Gainesville
country: United States
facility: United Osteoporosis Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern Center for Clinical Research
state: Illinois
city: Des Moines
country: United States
facility: Mercy Arthritis and Osteoporosis Center
state: Iowa
city: Bangor
country: United States
facility: St. Joseph Hospital
state: Maine
city: Hagerstown
country: United States
facility: Osteoporosis and Clinical Trials Center
state: Maryland
city: Albuquerque
country: United States
facility: New Mexico Clinical Research and Osteoporosis Center
state: New Mexico
city: West Haverstraw
country: United States
facility: Helen Hayes Hospital
state: New York
city: Cincinnati
country: United States
facility: UC Bone Health and Osteoporosis Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Wyomissing
country: United States
facility: Radiant Research
state: Pennsylvania
city: Norfolk
country: United States
facility: Hampton Roads Center for Clinical Research
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Sydney
country: Australia
facility: Garvan Institute of Medical Research
state: New South Wales
city: Daw Park
country: Australia
facility: Repatriation General Hospital
state: South Australia
city: Nedlands
country: Australia
facility: Keogh Institute for Medical Research
state: Western Australia
city: Vancouver
country: Canada
facility: Clinical Research Center
state: British Columbia
city: Halifax
country: Canada
facility: QEII HealthSciences Center
state: Nova Scotia
city: Hamilton
country: Canada
facility: Charlton Medical Building
state: Ontario
city: Laval
country: Canada
facility: Centre De Recherche Clinique De Laval
state: Quebec
city: Montreal
country: Canada
facility: Royal Victoria Hospital
state: Quebec
city: Sainte-Foy
country: Canada
facility: Groupe de Recherche en Rhumatologie et Maladies Osseuses
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Osteoporosis Center
state: Saskatchewan
Study officials:
References:
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.