Efficacy and Safety of Zoledronic Acid for the Treatment of Osteoporosis in Men
1 other identifier
interventional
288
3 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2004
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 30, 2004
CompletedFirst Posted
Study publicly available on registry
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedApril 27, 2012
April 1, 2012
3.3 years
November 30, 2004
April 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Male, 25-85 years old
You may not qualify if:
- Current users of bisphosphonates such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel ® (residronate), Skelid® (tiludronate)
- History of severe liver, kidney or eye disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Catalina Pointe Clinical Research Inc.
Tucson, Arizona, 85704, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Colorado Center for Bone Research
Lakewood, Colorado, 80227, United States
Radiant Research
Stuart, Florida, 34996, United States
United Osteoporosis Center
Gainesville, Georgia, 30501, United States
Northwestern Center for Clinical Research
Chicago, Illinois, 60611, United States
Mercy Arthritis and Osteoporosis Center
Des Moines, Iowa, 50322, United States
St. Joseph Hospital
Bangor, Maine, 04401, United States
Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, 21740, United States
New Mexico Clinical Research and Osteoporosis Center
Albuquerque, New Mexico, 87106, United States
Helen Hayes Hospital
West Haverstraw, New York, 10993, United States
UC Bone Health and Osteoporosis Center
Cincinnati, Ohio, 45219, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
Radiant Research
Wyomissing, Pennsylvania, 19610, United States
Hampton Roads Center for Clinical Research
Norfolk, Virginia, 23502, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Garvan Institute of Medical Research
Sydney, New South Wales, 2010, Australia
Repatriation General Hospital
Daw Park, South Australia, 5041, Australia
Keogh Institute for Medical Research
Nedlands, Western Australia, 6009, Australia
Clinical Research Center
Vancouver, British Columbia, V5Z 2N6, Canada
QEII HealthSciences Center
Halifax, Nova Scotia, B3H 2Y9, Canada
Charlton Medical Building
Hamilton, Ontario, L8N 1Y2, Canada
Centre De Recherche Clinique De Laval
Laval, Quebec, H7T 2P5, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Groupe de Recherche en Rhumatologie et Maladies Osseuses
Sainte-Foy, Quebec, G1V 3M7, Canada
Saskatoon Osteoporosis Center
Saskatoon, Saskatchewan, S7K 0H6, Canada
Related Publications (1)
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.
PMID: 21037195DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2004
First Posted
December 1, 2004
Study Start
April 1, 2004
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
April 27, 2012
Record last verified: 2012-04