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

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ClinicalTrials.gov Identifier: NCT00097825
Recruitment Status : Completed
First Posted : December 1, 2004
Last Update Posted : April 27, 2012
Sponsor:
Information provided by:
Novartis

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 Type : Interventional  (Clinical Trial)
Enrollment : 288 participants
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 : April 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources




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


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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097825


  Show 26 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00097825     History of Changes
Other Study ID Numbers: CZOL446M2308
First Posted: December 1, 2004    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by Novartis:
Male Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs