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Trial record 11 of 22 for:    paget's disease of bone

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®

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ClinicalTrials.gov Identifier: NCT00668200
Recruitment Status : Completed
First Posted : April 29, 2008
Results First Posted : March 3, 2014
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 81
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 80
Safety Population 81 [1]
Intent to Treat (ITT) 80
Completed 77
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Lost to Follow-up             1
[1]
1 patient was not included in the ITT patient was enrolled in error
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 80
Hide Baseline Analysis Population Description
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
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants
71.5  (12.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants
Female
29
  36.3%
Male
51
  63.7%
1.Primary Outcome
Title Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
Hide Description To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.
Time Frame at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population which includes 81 patients was used. 75 of the 81 patients in the safety population met the criteria. 6 patients did not meet criteria and were excluded from the analysis: 1 patient had a low serum calcium at baseline, and the other 5 patients were missing serum calcium values either at baseline or post-baseline.
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: percentage of patients
Visit 2 1.3
Visit 3 0.0
2.Secondary Outcome
Title Change From Baseline in Serum Calcium (mmol/L) – Safety Population
Hide Description Change from baseline = endpoint – baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.
Time Frame Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure uses Safety population which includes 81 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. The ITT population was used for participant flow and baseline characteristics.
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: mmol/L
Visit 2 n=76 -0.024  (0.189)
Visit 3 n=2 0.04  (0.014)
3.Secondary Outcome
Title Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Hide Description The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.
Time Frame End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure uses Safety population which includes 81 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. The ITT population was used for participant flow and baseline characteristics.
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 81
Measure Type: Number
Unit of Measure: percentage of patients
Tingling around your mouth n=76 1.3
Tingling in fingers n=66 3
Cramps in hands n=62 3.2
Cramps in leg or feet n=50 0
Involuntary movements of hands n=73 2.7
Involuntary movements of feet n=70 1.4
Involuntary movements of facial muscles n=71 0
Generalized (epileptic) seizures n=76 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description 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.
All-Cause Mortality
Zoledronic Acid
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zoledronic Acid
Affected / at Risk (%)
Total   1/81 (1.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastatic neoplasm  1  1/81 (1.23%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoledronic Acid
Affected / at Risk (%)
Total   24/81 (29.63%) 
General disorders   
Acute phase reaction  1  6/81 (7.41%) 
Chills  1  10/81 (12.35%) 
Malaise  1  6/81 (7.41%) 
Pain  1  9/81 (11.11%) 
Pyrexia  1  5/81 (6.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 8627788300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00668200     History of Changes
Other Study ID Numbers: CZOL446K2401
First Submitted: April 22, 2008
First Posted: April 29, 2008
Results First Submitted: November 4, 2013
Results First Posted: March 3, 2014
Last Update Posted: March 6, 2015