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Trial record 7 of 15 for:    "Paget disease of bone"

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

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ClinicalTrials.gov Identifier: NCT00051636
Recruitment Status : Completed
First Posted : January 15, 2003
Results First Posted : May 7, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Paget's Disease of Bone
Interventions: Drug: Zoledronic Acid
Drug: Risedronate
Drug: Placebo to Risedronate
Drug: Placebo to Zoledronic Acid
Dietary Supplement: Calcium and Vitamin D

  Participant Flow

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
172 participants entered period 1; of these, 127 were identified as treatment responders and entered the extended observation period 2. Responders defined as patient who had ≥75% decrease from baseline in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint of normal range) or SAP within normal range at 6 months.

Reporting Groups
  Description
Zoledronic Acid and Placebo to Risedronate Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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   90   82 
COMPLETED   86   76 
NOT COMPLETED   4   6 
Adverse Event                2                2 
Protocol Violation                1                0 
Withdrawal by Subject                1                2 
Lost to Follow-up                0                2 

Period 2:   Period 2- Extended Observation Period
    Zoledronic Acid and Placebo to Risedronate   Risedronate and Placebo to Zoledronic Acid
STARTED   75   52 
COMPLETED   5 [1]   22 [2] 
NOT COMPLETED   70   30 
Lost to Follow-up                5                4 
withdrew for nonclinical reason                12                7 
Clinical reasons other than Paget's                9                2 
Death                4                5 
Amendment 6 Informed Consent Not Signed                40                12 
[1] Includes patients retreated for Paget's disease and patients discontinued when sponsor ended study
[2] Includes patients retreated for Paget's disease



  Baseline Characteristics

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 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units 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 
Overall Participants Analyzed 
[Units: Participants]
 90   82   172 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.4  (10.25)   72.1  (9.91)   71.2  (10.10) 
Gender 
[Units: Participants]
     
Female   28   21   49 
Male   62   61   123 


  Outcome Measures

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

2.  Secondary:   Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28   [ Time Frame: Baseline and day 28 ]

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 Alpha C-telopeptide (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 Relative to Baseline   [ Time Frame: Baseline and day 28 ]

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

8.  Secondary:   Change in Pain Interference Score   [ 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 the maximum ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00051636     History of Changes
Obsolete Identifiers: NCT00050258
Other Study ID Numbers: CZOL446H2304
ZOL446K2304 ( Other Identifier: Novartis Pharmaceuticals )
First Submitted: January 14, 2003
First Posted: January 15, 2003
Results First Submitted: April 5, 2012
Results First Posted: May 7, 2012
Last Update Posted: May 15, 2012