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An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799266
Recruitment Status : Completed
First Posted : November 27, 2008
Results First Posted : July 5, 2019
Last Update Posted : September 2, 2020
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 Osteoporosis
Interventions Drug: Zoledronic acid
Drug: Placebo
Enrollment 34
Recruitment Details This study was conducted in 12 centers in 6 countries: Australia (1), Canada (5), Hungary (1), United Kingdom (2), Russian Federation (2), and South Africa (1).
Pre-assignment Details The Participant Flow and Baseline Characteristics were done on the Intention-to-treat (ITT) population. All efficacy analyses were done on the Modified Intention-to-treat (MITT) population and all safety analyses were based on Safety population.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Period Title: Overall Study
Started [1] 18 16
Modified Intention-to-treat (MITT) [2] 17 16
Safety Set [3] 18 16
Completed 15 15
Not Completed 3 1
Reason Not Completed
Adverse Event             0             1
Subject withdrew consent             3             0
[1]
All randomized patients (ITT)
[2]
All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
[3]
All patients with at least one infusion of study drug
Arm/Group Title Zoledronic Acid Placebo Total
Hide Arm/Group Description Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid Twice yearly i.v of infusion of Placebo (similar dosing as active drug) Total of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
The Participant Flow and Demographics (age/gender/race) were done on the Intention-to-treat (IIT) population whereas the Baseline disease characteristics were on the Modified Intention-to-treat (MITT). All efficacy analyses were done on the Modified Intention-to-treat (MITT) population and all safety analyses were based on Safety population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
13.0  (3.50) 12.3  (3.42) 12.6  (3.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
6
  33.3%
5
  31.3%
11
  32.4%
Male
12
  66.7%
11
  68.8%
23
  67.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Caucasian Number Analyzed 18 participants 16 participants 34 participants
13 14 27
Black Number Analyzed 18 participants 16 participants 34 participants
2 1 3
Asian Number Analyzed 18 participants 16 participants 34 participants
2 0 2
Native American Number Analyzed 18 participants 16 participants 34 participants
1 1 2
Pacific Islander Number Analyzed 18 participants 16 participants 34 participants
0 0 0
Othe Number Analyzed 18 participants 16 participants 34 participants
0 0 0
Lumbar Spine Bone Mineral Density (BMD) Z-score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Z-score
Number Analyzed 17 participants 16 participants 33 participants
-2.127  (0.7863) -2.379  (0.8975) -2.249  (0.8385)
[1]
Measure Description: Lumbar Spine Bone Mineral Density (BMD) Z-score in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. Bone mass, as measured by DXA, is reported as BMC (g) or areal BMD (g/cm2). These values are compared with reference values from healthy youth of similar age, sex, and race/ ethnicity to calculate a z score, the number of SDs from the expected mean. A BMC or BMD z score that is >2 SDs below expected (< -2.0) is referred to as "low for age".
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Lumbar Spine Bone Mineral Content (BMC)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Gram (g)
Number Analyzed 17 participants 16 participants 33 participants
31.886  (15.1062) 22.605  (6.6054) 27.386  (12.5195)
[1]
Measure Description: Lumbar Spine Bone Mineral Content (BMC) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Total body Bone Mineral Content (BMC)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Gram (g)
Number Analyzed 16 participants 14 participants 30 participants
1550.556  (592.0670) 1050.610  (253.0759) 1317.248  (523.8133)
[1]
Measure Description: Total body Bone Mineral Content (BMC) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Serum Procollagen type 1 amino-terminal propeptide (P1NP)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Nanogram per milliliter (ng/mL)
Number Analyzed 16 participants 14 participants 30 participants
313.54  (284.541) 368.90  (235.226) 339.37  (259.750)
[1]
Measure Description: Serum Procollagen type 1 amino-terminal propeptide (P1NP) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Serum Bone specific alkaline phosphatase (BSAP)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Nanogram per milliliter (ng/mL)
Number Analyzed 16 participants 14 participants 30 participants
31.559  (22.6619) 43.414  (32.8200) 37.092  (28.0122)
[1]
Measure Description: Serum Bone specific alkaline phosphatase (BSAP) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Serum Cross linked N-telopeptide (NTX)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Nmol BCE/L
Number Analyzed 16 participants 14 participants 30 participants
34.359  (22.0490) 39.192  (14.5823) 36.615  (18.7829)
[1]
Measure Description: Serum Cross linked N-telopeptide (NTX) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP-5b)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 16 participants 14 participants 30 participants
7.010  (2.9998) 8.595  (4.5650) 7.750  (3.8266)
[1]
Measure Description: Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP-5b) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Vertebral Morphometry (mid-to-posterior height ratio)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mid-to-posterior height ratio
Number Analyzed 10 participants 13 participants 23 participants
0.982  (0.0428) 0.976  (0.0788) 0.979  (0.0643)
[1]
Measure Description: Vertebral Morphometry (mid-to-posterior height ratio) in the Modified Intention-to-treat (MITT) population. Calculation was done using average ratio between mid-height and posterior height from L1 to L4 and analysis of covariance model was used with treatment, pooled centers, underlying condition treated with glucocordicoids and baseline value as explanatory variables and pooled centers as random effect.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
Second metacarpal cortical width   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Millimeter (mm)
Number Analyzed 9 participants 12 participants 21 participants
0.40  (0.194) 0.41  (0.144) 0.40  (0.163)
[1]
Measure Description: Second metacarpal cortical width in the Modified Intention-to-treat (MITT) population. Metacarpal cortical width of "0" was not included. An analysis of covariance model used with treatment, pooled centers, underlying condition treated with glucocorticoids at baseline value as explanatory variables and pooled centers as random effect.
[2]
Measure Analysis Population Description: Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score
1.Primary Outcome
Title Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12
Hide Description Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 12. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: Z-score
0.582  (0.1279) 0.168  (0.1449)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Lumbar Spine BMD Z-score at Month 12
Type of Statistical Test Superiority
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0392
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 0.414
Confidence Interval (2-Sided) 95%
0.022 to 0.806
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6
Hide Description Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 6. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: Z-score
0.447  (0.13) 0.157  (0.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Lumbar Spine BMD Z-score at Month 6
Type of Statistical Test Superiority
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.1322
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 0.290
Confidence Interval (2-Sided) 95%
-0.094 to 0.673
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12
Hide Description Lumbar Spine BMC was determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.
Time Frame Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: g
Lumbar Spine (LS) BMC Change at Month 6 Number Analyzed 16 participants 15 participants
4.110  (0.63) 2.131  (0.70)
Lumbar Spine (LS) BMC Change at Month 12 Number Analyzed 16 participants 15 participants
6.450  (1.18) 4.295  (1.32)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Lumbar Spine BMC at Month 6
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0409
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 1.979
Confidence Interval (2-Sided) 95%
0.089 to 3.869
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Lumbar Spine BMC at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.2340
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 2.155
Confidence Interval (2-Sided) 95%
-1.488 to 5.798
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Change From Baseline in Total Body BMC at Month 6 and 12
Hide Description Total body BMC was all determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.
Time Frame Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: g
Total BMC Change at Month 6 Number Analyzed 15 participants 13 participants
129.272  (24.23) 95.214  (28.74)
Total BMC Change at Month 12 Number Analyzed 15 participants 12 participants
220.805  (42.74) 140.064  (51.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Total Body BMC at Month 6
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.3827
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 34.058
Confidence Interval (2-Sided) 95%
-45.385 to 113.502
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Total Body BMC at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.2634
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value 80.741
Confidence Interval (2-Sided) 95%
-65.602 to 227.084
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in Serum P1NP at Months 6 and 12
Hide Description Serum Procollagen type 1 amino-terminal propeptide (P1NP) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Time Frame Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: nanogram per milliliter (ng/mL)
P1NP Change at Month 6 Number Analyzed 14 participants 15 participants
-134.285  (48.80) 77.497  (56.15)
P1NP Change at Month 12 Number Analyzed 15 participants 15 participants
-230.966  (59.1977) 150.166  (68.0933)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum P1NP at Month 6
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0631
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -211.782
Confidence Interval (2-Sided) 95%
-363.765 to -59.800
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum P1NP at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0049
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -381.132
Confidence Interval (2-Sided) 95%
-565.416 to -196.848
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Change From Baseline in BSAP at Months 6 and 12
Hide Description Bone specific alkaline phosphatase (BSAP) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Time Frame Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: nanogram per milliliter (ng/mL)
BSAP Change at Month 6 Number Analyzed 14 participants 15 participants
-7.413  (3.63) 3.810  (4.05)
BSAP Change at Month 12 Number Analyzed 15 participants 15 participants
-13.984  (4.3814) 6.450  (4.9010)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum BSAP at Month 6
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.2129
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -11.223
Confidence Interval (2-Sided) 95%
-22.595 to 0.149
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum BSAP at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0215
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -20.435
Confidence Interval (2-Sided) 95%
-33.960 to -6.909
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline in Serum NTX at Months 6 and 12
Hide Description Serum Cross linked N-telopeptide (NTX) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Time Frame Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: nmol BCE/L
NTX Change at Month 6 Number Analyzed 14 participants 15 participants
-13.746  (4.23) 7.192  (4.74)
NTX Change at Month 12 Number Analyzed 15 participants 15 participants
-20.134  (3.76) 7.440  (4.23)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum NTX at Month 6
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0254
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -20.938
Confidence Interval (2-Sided) 95%
-33.766 to -8.110
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum NTX at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -27.574
Confidence Interval (2-Sided) 95%
-39.037 to -16.111
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12
Hide Description Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Time Frame Month 6, Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: U/L
TRAP 5b Change at Month 6 Number Analyzed 14 participants 15 participants
-1.561  (0.65) 0.313  (0.74)
TRAP 5b Change at Month 12 Number Analyzed 14 participants 15 participants
-1.728  (0.73) 0.109  (0.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum TRAP-5b at Month 6
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.2178
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.874
Confidence Interval (2-Sided) 95%
-3.931 to 0.182
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Serum TRAP-5b at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.1840
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -1.837
Confidence Interval (2-Sided) 95%
-4.103 to 0.429
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants With New Vertebral Fractures at Month 12
Hide Description New vertebral fractures were defined as fractures of Genant Grade 1 or higher that occurred at lumbar or thoracic spine from first dose infusion to the end of the study.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  12.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments New vertebral fractures at Month 12
Type of Statistical Test Other
Comments The number and percentage of patients with new vertebral fractures at Month 12 were presented by treatment group and between-treatment differences were evaluated using Fisher's exact test.
Statistical Test of Hypothesis P-Value 0.2258
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline in Vertebral Morphometry at Month 12
Hide Description Vertebral morphometry (or concave index) was calculated using the average ratio between mid-height and posterior height from L1 to L4 and performed by a central reader.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: Ratio
-0.018  (0.01) -0.0003  (0.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Vertebral morphometry at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.3180
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -0.018
Confidence Interval (2-Sided) 95%
-0.055 to 0.019
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12
Hide Description Pain was evaluated at each visit (in office and telephone visit) at randomization, Months 3, 6, 9 and 12 using the Faces Pain Scale-Revised (FPS-R). Children were selecting the face that best fits their pain. The pain score ranged from 0 (No Pain) to 10 (Very Much Pain). The reduction in pain from baseline by visit was evaluated based on whether or not patients had a decrease in their FPS-R from baseline. If pain remained the same or worsened from baseline a patient was classified as '0' and if the pain scale decreased then the patient was classified as '1'.
Time Frame Month 3, Month 6, Month 9 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Measure Type: Number
Unit of Measure: Percentage of Patients
Month 3 Number Analyzed 16 participants 13 participants
37.5 53.8
Month 6 Number Analyzed 16 participants 14 participants
37.5 50.0
Month 9 Number Analyzed 15 participants 13 participants
33.3 46.2
Month 12 Number Analyzed 16 participants 14 participants
31.3 57.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Reduction in Pain at Month 3
Type of Statistical Test Other
Comments Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.
Statistical Test of Hypothesis P-Value 0.5226
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.45
Confidence Interval (2-Sided) 95%
0.04 to 5.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Reduction in Pain at Month 6
Type of Statistical Test Other
Comments Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.
Statistical Test of Hypothesis P-Value 0.5220
Comments >999.99 (<0.01, >999.99)
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 999.99
Confidence Interval (2-Sided) 95%
0.01 to 999.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Reduction in Pain at Month 9
Type of Statistical Test Other
Comments Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.
Statistical Test of Hypothesis P-Value 0.6019
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.04 to 6.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments Reduction in Pain at Month 12
Type of Statistical Test Other
Comments Presented by treatment group and evaluated using a logistic regression model with treatment, pooled centers, underlying condition treated with glucocorticoids and baseline pain score as explanatory variables.
Statistical Test of Hypothesis P-Value 0.9652
Comments 0.45 (<0.01, >999.99)
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.45
Confidence Interval (2-Sided) 0.9652%
0.01 to 999.99
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12
Hide Description Left posteroanterior (PA) hand/wrist X-ray were taken at Visit 1 and at the Month 12 visit to assess bone age and the between-treatment differences for change in 2nd metacarpal cortical width at Month 12 relative to baseline. If a fracture of the left upper extremity precluded radiographic imaging, then the right hand was evaluated for this purpose. In this case, the right hand was be imaged at both Visit 1 and at Month 12. The information was used in the assessment of bone density.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 17 16
Least Squares Mean (Standard Error)
Unit of Measure: millimeter (mm)
-0.01  (0.040) 0.03  (0.047)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zoledronic Acid, Placebo
Comments 2nd metacarpal cortical width at Month 12
Type of Statistical Test Other
Comments Difference in least squares (LS) = LS mean for the zoledronic acid group-LS mean for the placebo group.
Statistical Test of Hypothesis P-Value 0.5165
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS mean
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.17 to 0.09
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Urinary Concentration of Zoledronic Acid at Month 12
Hide Description Urine was collected overnight or for at least 4 waking hours from all patients able to provide specimens, to measure urinary concentration of zoledronic acid at Month 12. Only descriptive analysis done.
Time Frame Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified Intention-to-treat (MITT) population, which consisted of all randomized patients who had both baseline and at least one post-baseline lumbar spine BMD Z-score, was considered.
Arm/Group Title Zoledronic Acid
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
1643.3  (2846.34)
14.Secondary Outcome
Title Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids
Hide Description Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that zoledronic acid is safe for the treatment of osteoporotic children treated with glucocorticoids through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis done.
Time Frame Baseline through Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug, was considered.
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description:
Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
Overall Number of Participants Analyzed 18 16
Measure Type: Number
Unit of Measure: Percentage of Participants
AEs by Primary System Organ Class (SOC) Number Analyzed 15 participants 12 participants
83.3 75.0
SAEs by Primary System Organ Class (SOC) Number Analyzed 5 participants 1 participants
27.8 6.3
Deaths by Primary System Organ Class (SOC) Number Analyzed 0 participants 0 participants
Time Frame Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 9 years and 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zoledronic Acid Placebo
Hide Arm/Group Description Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
All-Cause Mortality
Zoledronic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Zoledronic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   5/18 (27.78%)   1/16 (6.25%) 
Gastrointestinal disorders     
Abdominal pain  1  1/18 (5.56%)  0/16 (0.00%) 
Crohn's disease  1  2/18 (11.11%)  0/16 (0.00%) 
Diarrhoea  1  1/18 (5.56%)  0/16 (0.00%) 
Nausea  1  1/18 (5.56%)  0/16 (0.00%) 
Vomiting  1  1/18 (5.56%)  0/16 (0.00%) 
General disorders     
Acute phase reaction  1  1/18 (5.56%)  0/16 (0.00%) 
Pyrexia  1  1/18 (5.56%)  0/16 (0.00%) 
Infections and infestations     
Clostridium difficile infection  1  1/18 (5.56%)  0/16 (0.00%) 
Varicella zoster virus infection  1  0/18 (0.00%)  1/16 (6.25%) 
Investigations     
Weight decreased  1  1/18 (5.56%)  0/16 (0.00%) 
Metabolism and nutrition disorders     
Hypocalcaemia  1  1/18 (5.56%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders     
Bone pain  1  1/18 (5.56%)  0/16 (0.00%) 
Myalgia  1  1/18 (5.56%)  0/16 (0.00%) 
Nervous system disorders     
Headache  1  1/18 (5.56%)  0/16 (0.00%) 
Seizure  1  1/18 (5.56%)  0/16 (0.00%) 
Status epilepticus  1  1/18 (5.56%)  0/16 (0.00%) 
Psychiatric disorders     
Abnormal behaviour  1  1/18 (5.56%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Zoledronic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/18 (77.78%)   12/16 (75.00%) 
Cardiac disorders     
Tachycardia  1  3/18 (16.67%)  0/16 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  3/18 (16.67%)  0/16 (0.00%) 
Eye disorders     
Dry eye  1  0/18 (0.00%)  1/16 (6.25%) 
Eye disorder  1  0/18 (0.00%)  1/16 (6.25%) 
Eye pruritus  1  0/18 (0.00%)  1/16 (6.25%) 
Lacrimation increased  1  1/18 (5.56%)  0/16 (0.00%) 
Gastrointestinal disorders     
Abdominal discomfort  1  2/18 (11.11%)  0/16 (0.00%) 
Abdominal pain upper  1  1/18 (5.56%)  0/16 (0.00%) 
Dental caries  1  0/18 (0.00%)  1/16 (6.25%) 
Diarrhoea  1  2/18 (11.11%)  2/16 (12.50%) 
Gastrooesophageal reflux disease  1  0/18 (0.00%)  1/16 (6.25%) 
Nausea  1  2/18 (11.11%)  2/16 (12.50%) 
Tooth erosion  1  0/18 (0.00%)  1/16 (6.25%) 
Vomiting  1  3/18 (16.67%)  1/16 (6.25%) 
General disorders     
Acute phase reaction  1  2/18 (11.11%)  0/16 (0.00%) 
Chills  1  1/18 (5.56%)  0/16 (0.00%) 
Fatigue  1  1/18 (5.56%)  2/16 (12.50%) 
Pain  1  3/18 (16.67%)  0/16 (0.00%) 
Pyrexia  1  3/18 (16.67%)  1/16 (6.25%) 
Thirst  1  1/18 (5.56%)  0/16 (0.00%) 
Immune system disorders     
Food allergy  1  1/18 (5.56%)  0/16 (0.00%) 
Infections and infestations     
Gastroenteritis  1  1/18 (5.56%)  0/16 (0.00%) 
Herpes zoster  1  0/18 (0.00%)  2/16 (12.50%) 
Influenza  1  1/18 (5.56%)  1/16 (6.25%) 
Localised infection  1  1/18 (5.56%)  1/16 (6.25%) 
Nasopharyngitis  1  0/18 (0.00%)  1/16 (6.25%) 
Otitis media  1  0/18 (0.00%)  1/16 (6.25%) 
Upper respiratory tract infection  1  2/18 (11.11%)  2/16 (12.50%) 
Varicella zoster virus infection  1  0/18 (0.00%)  1/16 (6.25%) 
Vulvovaginal candidiasis  1  1/18 (5.56%)  0/16 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  0/18 (0.00%)  1/16 (6.25%) 
Fall  1  1/18 (5.56%)  1/16 (6.25%) 
Fracture  1  0/18 (0.00%)  1/16 (6.25%) 
Fracture displacement  1  1/18 (5.56%)  0/16 (0.00%) 
Joint dislocation  1  1/18 (5.56%)  0/16 (0.00%) 
Ligament sprain  1  1/18 (5.56%)  0/16 (0.00%) 
Lumbar vertebral fracture  1  1/18 (5.56%)  0/16 (0.00%) 
Muscle strain  1  1/18 (5.56%)  0/16 (0.00%) 
Skin abrasion  1  1/18 (5.56%)  0/16 (0.00%) 
Tibia fracture  1  0/18 (0.00%)  1/16 (6.25%) 
Tooth fracture  1  0/18 (0.00%)  1/16 (6.25%) 
Investigations     
Blood iron decreased  1  1/18 (5.56%)  0/16 (0.00%) 
Transaminases increased  1  0/18 (0.00%)  1/16 (6.25%) 
Weight decreased  1  1/18 (5.56%)  0/16 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/18 (0.00%)  1/16 (6.25%) 
Dehydration  1  1/18 (5.56%)  0/16 (0.00%) 
Hypocalcaemia  1  1/18 (5.56%)  0/16 (0.00%) 
Vitamin B12 deficiency  1  0/18 (0.00%)  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/18 (27.78%)  1/16 (6.25%) 
Back pain  1  4/18 (22.22%)  1/16 (6.25%) 
Flank pain  1  1/18 (5.56%)  0/16 (0.00%) 
Limb discomfort  1  1/18 (5.56%)  0/16 (0.00%) 
Musculoskeletal discomfort  1  1/18 (5.56%)  0/16 (0.00%) 
Musculoskeletal pain  1  1/18 (5.56%)  1/16 (6.25%) 
Myalgia  1  2/18 (11.11%)  1/16 (6.25%) 
Pain in extremity  1  1/18 (5.56%)  0/16 (0.00%) 
Polyarthritis  1  1/18 (5.56%)  0/16 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma  1  1/18 (5.56%)  0/16 (0.00%) 
Nervous system disorders     
Ataxia  1  1/18 (5.56%)  0/16 (0.00%) 
Depressed level of consciousness  1  1/18 (5.56%)  0/16 (0.00%) 
Dizziness  1  1/18 (5.56%)  0/16 (0.00%) 
Headache  1  3/18 (16.67%)  1/16 (6.25%) 
Lethargy  1  1/18 (5.56%)  0/16 (0.00%) 
Psychiatric disorders     
Agitation  1  1/18 (5.56%)  0/16 (0.00%) 
Depression  1  1/18 (5.56%)  0/16 (0.00%) 
Sleep talking  1  1/18 (5.56%)  0/16 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/18 (5.56%)  0/16 (0.00%) 
Cough  1  0/18 (0.00%)  1/16 (6.25%) 
Dyspnoea  1  1/18 (5.56%)  0/16 (0.00%) 
Obstructive airways disorder  1  1/18 (5.56%)  0/16 (0.00%) 
Oropharyngeal pain  1  0/18 (0.00%)  1/16 (6.25%) 
Sneezing  1  1/18 (5.56%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders     
Eczema  1  0/18 (0.00%)  1/16 (6.25%) 
Erythema  1  0/18 (0.00%)  1/16 (6.25%) 
Keratosis pilaris  1  1/18 (5.56%)  0/16 (0.00%) 
Mechanical urticaria  1  1/18 (5.56%)  0/16 (0.00%) 
Vascular disorders     
Hypotension  1  1/18 (5.56%)  0/16 (0.00%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
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 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 the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: Novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00799266    
Other Study ID Numbers: CZOL446H2337
2008-001252-52 ( EudraCT Number )
First Submitted: November 26, 2008
First Posted: November 27, 2008
Results First Submitted: September 4, 2018
Results First Posted: July 5, 2019
Last Update Posted: September 2, 2020