3 yr Efficacy & Safety Study of Zoledronic Acid in Post-menopausal Women With Osteoporosis Treated With Zol Acid for 6 Yrs

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00718861
First received: July 18, 2008
Last updated: October 2, 2014
Last verified: September 2014
Results First Received: November 8, 2013  
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: Post-menopausal Osteoporosis
Interventions: Drug: Placebo
Drug: Zoledronic acid

  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
Z9 (Zoledronic Acid 9) Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
Z6P3 (Zoledronic Acid 6 Placebo 3) Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).

Participant Flow:   Overall Study
    Z9 (Zoledronic Acid 9)     Z6P3 (Zoledronic Acid 6 Placebo 3)  
STARTED     95 [1]   95  
Safety Set     92 [2]   95  
Modified Intent to Treat     67 [3]   69 [3]
COMPLETED     74     77  
NOT COMPLETED     21     18  
Withdrawal by Subject                 15                 10  
Adverse Event                 2                 1  
Lost to Follow-up                 2                 1  
Administrative Problems                 1                 1  
Death                 1                 5  
[1] "Started" indicates Randomized and Intent-to Treat (ITT) population
[2] 3 patients randomized but never received study drug
[3] ITT patients with DXA total hip measure at extension 2 baseline and year 9



  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.
The intent-to-treat (ITT) population included all patients who were enrolled in the extension study at Visit 12. This included patients who were randomized to Z9 and Z6P3 groups.

Reporting Groups
  Description
Z9 (Zoledronic Acid 9) Group Z9 patients were those who had been treated with zoledronic acid for up to 9 years in the core (CZOL446H2301) and extension studies (CZOL446H2301E1 and CZOL446H2301E2).
Z6P3 (Zoledronic Acid 6 Placebo 3) Group Z6P3 patients were those who had been treated with zoledronic acid for 6 years in the core (CZOL446H2301) and the first extension study (CZOL446H2301E1) followed by up to 3 years of placebo in the second extension study (CZOL446H2301E2).
Total Total of all reporting groups

Baseline Measures
    Z9 (Zoledronic Acid 9)     Z6P3 (Zoledronic Acid 6 Placebo 3)     Total  
Number of Participants  
[units: participants]
  95     95     190  
Age  
[units: Years]
Mean ± Standard Deviation
  78  ± 4.71     78.1  ± 4.85     78.1  ± 4.77  
Gender  
[units: participants]
     
Female     95     95     190  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage Change in Total Hip Bone Mineral Density BMD at Year 6 (Baseline) and Year 9   [ Time Frame: Year 6 (baseline) and Year 9 ]

2.  Secondary:   Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7 and 8 Compared to Year 6   [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8 ]

3.  Secondary:   Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 6   [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ]

4.  Secondary:   Percentage Change of Total Hip Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0   [ Time Frame: Year 0 (core baseline), Year 7, Year 8, Year 9 ]

5.  Secondary:   Percentage Change of Femoral Neck Bone Mineral Density (BMD) at Year 7, 8 and 9 Compared to Year 0   [ Time Frame: Year 0 (core baseline), Year 7, Year 8, Year 9 ]

6.  Secondary:   Biomarkers (Bone Markers) Serum C-terminal Telopeptide of Type I Collagen (CTx) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9   [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ]

7.  Secondary:   Biomarkers (Bone Markers)Serum N-terminal Propeptide of Type I Collagen (P1NP) at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9   [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ]

8.  Secondary:   Biomarkers (Bone Markers) Serum Bone-specific Alkaline Phosphatase (BSAP). at Year 6 (Extension 2 Baseline), Year 7, Year 8, Year 9   [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ]

9.  Secondary:   Number of Participants With New/Worsening Morphometric Vertebral Fractures at Year 9 Compared to Year 6   [ Time Frame: Year 6 (extension 2 baseline), Year 9 (3 years of study duration) ]

10.  Secondary:   Mean of Time to First Clinical Fracture   [ Time Frame: over 3 years of study duration ]

11.  Secondary:   Change in Height at Years 7, 8 and 9 Relative to Year 6   [ Time Frame: Year 6 (extension 2 baseline), Year 7, Year 8, Year 9 ]


  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: Study Director
Organization: Novartis Pharmaceuticals
phone: 8627788300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00718861     History of Changes
Other Study ID Numbers: CZOL446H2301E2, 2007-005383-27
Study First Received: July 18, 2008
Results First Received: November 8, 2013
Last Updated: October 2, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Ministry of Health
Canada: Canadian Institutes of Health Research
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Russia: Ministry of Health of the Russian Federation
Switzerland: Swissmedic
Thailand: Ministry of Public Health