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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001252-52 | EudraCT Number |
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This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids
In March 2017, Novartis stopped enrollment as the study was not feasible to be conducted due to low enrollment and other recruitment challenges. Patients receiving the treatment continued to receive the treatment per protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic acid | Experimental | Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid |
|
| Placebo | Placebo Comparator | Twice yearly i.v of infusion of Placebo (similar dosing as active drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic acid | Drug | intravenous infusion |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12 | 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. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6 | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34228102 | Derived | Ward LM, Choudhury A, Alos N, Cabral DA, Rodd C, Sbrocchi AM, Taback S, Padidela R, Shaw NJ, Hosszu E, Kostik M, Alexeeva E, Thandrayen K, Shenouda N, Jaremko JL, Sunkara G, Sayyed S, Aftring RP, Munns CF. Zoledronic Acid vs Placebo in Pediatric Glucocorticoid-induced Osteoporosis: A Randomized, Double-blind, Phase 3 Trial. J Clin Endocrinol Metab. 2021 Nov 19;106(12):e5222-e5235. doi: 10.1210/clinem/dgab458. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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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.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid | Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid |
| FG001 | Placebo | Twice yearly i.v of infusion of Placebo (similar dosing as active drug) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2015 | Sep 4, 2018 |
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| Drug |
intravenous infusion |
|
| Month 6 |
| Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12 | 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. | Month 6, Month 12 |
| Mean Change From Baseline in Total Body BMC at Month 6 and 12 | 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. | Month 6, Month 12 |
| Mean Change From Baseline in Serum P1NP at Months 6 and 12 | 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. | Month 6, Month 12 |
| Mean Change From Baseline in BSAP at Months 6 and 12 | 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. | Month 6, Month 12 |
| Mean Change From Baseline in Serum NTX at Months 6 and 12 | 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. | Month 6, Month 12 |
| Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12 | 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. | Month 6, Month 12 |
| Number of Participants With New Vertebral Fractures at Month 12 | 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. | Month 12 |
| Mean Change From Baseline in Vertebral Morphometry at Month 12 | 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. | Month 12 |
| Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12 | 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'. | Month 3, Month 6, Month 9 and Month 12 |
| Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12 | 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. | Month 12 |
| Urinary Concentration of Zoledronic Acid at Month 12 | 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. | Month 12 |
| Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids | 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. | Baseline through Month 12 |
| Vancouver |
| British Columbia |
| V6H 3V4 |
| Canada |
| Novartis Investigative Site | Winnipeg | Manitoba | R3E 0Z2 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L1 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3H 1P3 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1C5 | Canada |
| Novartis Investigative Site | Budapest | 1085 | Hungary |
| Novartis Investigative Site | Moscow | 119991 | Russia |
| Novartis Investigative Site | Saint Petersburg | 195067 | Russia |
| Novartis Investigative Site | Soweto | Gauteng | 2013 | South Africa |
| Novartis Investigative Site | West Midlands | Birmingham | B4 6NH | United Kingdom |
| Novartis Investigative Site | Manchester | M14 0JH | United Kingdom |
|
| Modified Intention-to-treat (MITT) | All patients with baseline and at least one post-baseline lumbar spine BMD Z-score |
|
| Safety Set | All patients with at least one infusion of study drug |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid | Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid |
| BG001 | Placebo | Twice yearly i.v of infusion of Placebo (similar dosing as active drug) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| ||||||||||||||||
| Lumbar Spine Bone Mineral Density (BMD) Z-score | 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". | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | Z-score |
| |||||||||||||
| Lumbar Spine Bone Mineral Content (BMC) | Lumbar Spine Bone Mineral Content (BMC) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | gram (g) |
| |||||||||||||
| Total body Bone Mineral Content (BMC) | Total body Bone Mineral Content (BMC) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | gram (g) |
| |||||||||||||
| Serum Procollagen type 1 amino-terminal propeptide (P1NP) | Serum Procollagen type 1 amino-terminal propeptide (P1NP) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | nanogram per milliliter (ng/mL) |
| |||||||||||||
| Serum Bone specific alkaline phosphatase (BSAP) | Serum Bone specific alkaline phosphatase (BSAP) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | nanogram per milliliter (ng/mL) |
| |||||||||||||
| Serum Cross linked N-telopeptide (NTX) | Serum Cross linked N-telopeptide (NTX) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | nmol BCE/L |
| |||||||||||||
| Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP-5b) | Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP-5b) in the Modified Intention-to-treat (MITT) population. No imputation done at Baseline. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | U/L |
| |||||||||||||
| Vertebral Morphometry (mid-to-posterior height ratio) | 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. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | mid-to-posterior height ratio |
| |||||||||||||
| Second metacarpal cortical width | 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. | Modified Intention-to-treat (MITT) population = All patients with baseline and at least one post-baseline lumbar spine BMD Z-score | Mean | Standard Deviation | millimeter (mm) |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Z-score | Month 12 |
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| Secondary | Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Z-score | Month 6 |
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| Secondary | Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | g | Month 6, Month 12 |
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| Secondary | Mean Change From Baseline in Total Body BMC at Month 6 and 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | g | Month 6, Month 12 |
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| Secondary | Mean Change From Baseline in Serum P1NP at Months 6 and 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | nanogram per milliliter (ng/mL) | Month 6, Month 12 |
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| Secondary | Mean Change From Baseline in BSAP at Months 6 and 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | nanogram per milliliter (ng/mL) | Month 6, Month 12 |
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| Secondary | Mean Change From Baseline in Serum NTX at Months 6 and 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | nmol BCE/L | Month 6, Month 12 |
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| Secondary | Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | U/L | Month 6, Month 12 |
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| Secondary | Number of Participants With New Vertebral Fractures at Month 12 | 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. | 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. | Posted | Count of Participants | Participants | Month 12 |
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| Secondary | Mean Change From Baseline in Vertebral Morphometry at Month 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | Ratio | Month 12 |
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| Secondary | Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12 | 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'. | 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. | Posted | Number | Percentage of Patients | Month 3, Month 6, Month 9 and Month 12 |
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| Secondary | Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12 | 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. | 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. | Posted | Least Squares Mean | Standard Error | millimeter (mm) | Month 12 |
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| Secondary | Urinary Concentration of Zoledronic Acid at Month 12 | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Month 12 |
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| Secondary | Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids | 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. | The Safety population, which consisted of all patients who had been exposed to at least one infusion of study drug, was considered. | Posted | Number | Percentage of Participants | Baseline through Month 12 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid | Twice yearly 0.05 mg/kg (max 5 mg) i.v infusion (at least 30 minutes) of zoledronic acid | 0 | 18 | 5 | 18 | 14 | 18 |
| EG001 | Placebo | Twice yearly i.v of infusion of Placebo (similar dosing as active drug) | 0 | 16 | 1 | 16 | 12 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute phase reaction | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abnormal behaviour | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Tooth erosion | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Acute phase reaction | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Fracture displacement | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
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| Sleep talking | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Keratosis pilaris | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Mechanical urticaria | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2017 | Sep 4, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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