Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00439647
First received: February 22, 2007
Last updated: October 10, 2011
Last verified: October 2011
Results First Received: October 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Male Osteoporosis
Interventions: Drug: Zoledronic acid 5 mg iv
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Zoledronic Acid 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Placebo 100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.

Participant Flow:   Overall Study
    Zoledronic Acid     Placebo  
STARTED     588 [1]   611  
Modified Intent to Treat (mITT)     553     574  
COMPLETED     530     540  
NOT COMPLETED     58     71  
Withdrawal by Subject                 25                 22  
Death                 15                 18  
Adverse Event                 11                 11  
Lost to Follow-up                 4                 12  
Protocol Violation                 3                 4  
Lack of Efficacy                 0                 4  
[1] "Started" indicates intent to treat (ITT) and safety set.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Zoledronic Acid 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Placebo 100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid     Placebo     Total  
Number of Participants  
[units: participants]
  588     611     1199  
Age  
[units: years]
Mean ± Standard Deviation
  65.8  ± 8.3     65.7  ± 8.6     65.8  ± 8.5  
Gender  
[units: participants]
     
Female     0     0     0  
Male     588     611     1199  



  Outcome Measures
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1.  Primary:   Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 24 Months   [ Time Frame: 24 Months ]

2.  Secondary:   Percentage of Participants With at Least One New Morphometric Vertebral Fracture Over 12 Months   [ Time Frame: 12 Months ]

3.  Secondary:   Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 12 Months   [ Time Frame: 12 months ]

4.  Secondary:   Percentage of Participants With at Least One New Moderate or Severe Morphometric Vertebral Fracture Over 24 Months   [ Time Frame: 24 Months ]

5.  Secondary:   Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 12 Months   [ Time Frame: Baseline, 12 months ]

6.  Secondary:   Percentage of Participants With at Least One New or Worsening Morphometric Vertebral Fracture Over 24 Months   [ Time Frame: Baseline, Month 24 ]

7.  Secondary:   Mean Change in Height From Baseline   [ Time Frame: from Baseline to 12 months and 24 months ]

8.  Secondary:   Number of Participants With First Clinical Vertebral Fracture   [ Time Frame: 24 months ]

9.  Secondary:   Number of Participants With First Clinical Fracture   [ Time Frame: 24 months ]

10.  Secondary:   Number of Participants With First Non-vertebral Fracture   [ Time Frame: 24 months ]

11.  Secondary:   Percentage Change From Baseline in Lumbar Spine Bone Mass Density (BMD)   [ Time Frame: Month 6, Month 12, Month 24 ]

12.  Secondary:   Percentage Change From Baseline in Total Hip BMD (g/CM^2)   [ Time Frame: Month 6, Month 12, Month 24 ]

13.  Secondary:   Percentage Change From Baseline in Femoral Neck BMD (g/CM^2)   [ Time Frame: Month 6, Month 12, Month 24 ]

14.  Secondary:   Serum Beta C-terminal Telopeptides of Type I Collagen(b-CTx) by Visits   [ Time Frame: Baseline, Month 3, Month 6, Month 12, Month 15, month 18, Month 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Novartis Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00439647     History of Changes
Other Study ID Numbers: CZOL446M2309
Study First Received: February 22, 2007
Results First Received: October 10, 2011
Last Updated: October 10, 2011
Health Authority: Argentina: National Administration of Drugs, Foods and Medical Technology
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Romania: Ministry of Health and the Family
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Switzerland: Swiss Agency for Therapeudic Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council (MCC)
Iceland:"Lyfjastofnun" Icelandic Medicines Control Agency
Poland: Central Register of Clinical Trials. The office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Italy: Ministero della Salute
Austria: Bundesamt für Sicherheit im Gesundheitswesen. AGES PharmMed, WIN/NATA
Australia:Therapeutic Goods Administration (TGA)
Russia:Federal Service on Surveillance in Healthcare and Social Development of Russian Federation