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Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00103740
First received: February 14, 2005
Last updated: May 29, 2012
Last verified: May 2012
Results First Received: April 5, 2012  
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: Paget's Disease of Bone
Interventions: Drug: zoledronic acid
Drug: placebo to zoledronic acid
Drug: Risedronate
Drug: Placebo to risedronate
Drug: Calcium and vitamin D supplements

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
371 patients were screened. 185 patients were randomized.

Reporting Groups
  Description
Zoledronic Acid and Placebo to Risedronate Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Risedronate and Placebo to Zoledronic Acid Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.

Participant Flow for 2 periods

Period 1:   Period 1 - Core
    Zoledronic Acid and Placebo to Risedronate     Risedronate and Placebo to Zoledronic Acid  
STARTED     92     93  
COMPLETED     85     89  
NOT COMPLETED     7     4  
Adverse Event                 1                 0  
Protocol Violation                 3                 2  
Patient withdrew consent                 3                 2  

Period 2:   Period 2 - Extended Observation Period
    Zoledronic Acid and Placebo to Risedronate     Risedronate and Placebo to Zoledronic Acid  
STARTED     78     63  
COMPLETED     9 [1]   27 [1]
NOT COMPLETED     69     36  
Lost to Follow-up                 7                 6  
Withdrew for nonclinical reason                 21                 13  
Clinical reason other than Paget's                 5                 6  
Death                 6                 2  
Amendment 6 informed consent not signed                 30                 9  
[1] Includes patients retreated for Paget's disease and patients discontinued when sponsor ended study



  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 and Placebo to Risedronate Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Risedronate and Placebo to Zoledronic Acid Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid and Placebo to Risedronate     Risedronate and Placebo to Zoledronic Acid     Total  
Number of Participants  
[units: participants]
  92     93     185  
Age  
[units: years]
Mean ± Standard Deviation
  71.3  ± 9.42     68.2  ± 11.15     69.8  ± 10.41  
Gender  
[units: participants]
     
Female     30     36     66  
Male     62     57     119  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Who Had Therapeutic Response at 6 Months   [ Time Frame: Baseline, 6 months ]

2.  Secondary:   Relative Change in Serum Alkaline Phosphatase in U/L at Day 28   [ Time Frame: Baseline and 28 days ]

3.  Secondary:   Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10   [ Time Frame: Baseline and day 10 ]

4.  Secondary:   Relative Change in Urine α-CTx in ug/mmol at Day 10   [ Time Frame: Baseline and day 10 ]

5.  Secondary:   Time to First Therapeutic Response   [ Time Frame: 182 days ]

6.  Secondary:   Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28   [ Time Frame: Day 28 ]

7.  Secondary:   Change in Pain Severity at Day 182   [ Time Frame: Baseline and day 182 ]

8.  Secondary:   Change in Pain Interference at Day 182   [ Time Frame: Baseline and day 182 ]

9.  Secondary:   Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period   [ Time Frame: 8 years was the maximum ]

10.  Secondary:   Number of Participants With a Partial Disease Relapse During the Extended Observation Period   [ Time Frame: 8 years was the maximum ]

11.  Secondary:   Number of Participants With a Disease Relapse During the Extended Observation Period   [ Time Frame: 8 years was maximum ]


  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
No text entered.


  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: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00103740     History of Changes
Obsolete Identifiers: NCT00051649
Other Study ID Numbers: CZOL446H2305, ZOL446K2305
Study First Received: February 14, 2005
Results First Received: April 5, 2012
Last Updated: May 29, 2012
Health Authority: United States: Food and Drug Administration
New Zealand: Medsafe
Australia: Department of Health and Ageing Therapeutic Goods Administration
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
European Union: European Medicines Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
South Africa: Medicines Control Council