Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00668200
First received: April 22, 2008
Last updated: April 9, 2014
Last verified: April 2014
Results First Received: November 4, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Paget's Disease of the Bone
Hypocalcemia
Interventions: Drug: Reclast (ZOL446, zoledronic acid)
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D

  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
Enrollment number was 85 (4 pts screen failed + 81 pts). The ITT population includes 80 enrolled pts and the Safety population includes 81 enrolled pts. During monitoring it was discovered that 1 patient signed the consent form from another Paget’s study; so, this patient was excluded from the ITT population but included in the safety population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zoledronic Acid 5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.

Participant Flow:   Overall Study
    Zoledronic Acid  
STARTED     80  
COMPLETED     77  
NOT COMPLETED     3  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  



  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 ITT population includes 80 enrolled patients and the Safety population includes 81enrolled patients. During monitoring it was discovered that one patient signed the consent form from another Paget’s study; therefore, this patient was excluded from the ITT population but included in the safety population.Baseline used ITT data set

Reporting Groups
  Description
Zoledronic Acid 5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate.

Baseline Measures
    Zoledronic Acid  
Number of Participants  
[units: participants]
  80  
Age  
[units: years]
Mean ± Standard Deviation
  71.5  ± 12.98  
Gender  
[units: participants]
 
Female     29  
Male     51  



  Outcome Measures
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1.  Primary:   Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.   [ Time Frame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30) ]

2.  Secondary:   Change From Baseline in Serum Calcium (mmol/L) – Safety Population   [ Time Frame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30) ]

3.  Secondary:   Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)   [ Time Frame: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30) ]


  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: NCT00668200     History of Changes
Other Study ID Numbers: CZOL446K2401
Study First Received: April 22, 2008
Results First Received: November 4, 2013
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration