Trial · NCT00799266

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

NCT00799266, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2019-07-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids. Trials, record NCT00799266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00799266

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids
NCT number: NCT00799266
Status: Completed
Phases: Phase 3
Enrollment: 34 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Osteoporosis
Interventions: Zoledronic acid, Placebo
First posted: 2008-11-27
Last updated: 2020-09-02
Other registries' IDs: eudract:2008-001252-52
Results first posted: 2019-07-05

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12	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.
Secondary	Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6	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.
Secondary	Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12	Month 6, Month 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.
Secondary	Mean Change From Baseline in Total Body BMC at Month 6 and 12	Month 6, Month 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.
Secondary	Mean Change From Baseline in Serum P1NP at Months 6 and 12	Month 6, Month 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.
Secondary	Mean Change From Baseline in BSAP at Months 6 and 12	Month 6, Month 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.
Secondary	Mean Change From Baseline in Serum NTX at Months 6 and 12	Month 6, Month 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.
Secondary	Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12	Month 6, Month 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.
Secondary	Number of Participants With New Vertebral Fractures at Month 12	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.
Secondary	Mean Change From Baseline in Vertebral Morphometry at Month 12	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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12	Month 12	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.	Z-score	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6	Month 6	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.	Z-score	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12	Month 6, Month 12	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.	g	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Total Body BMC at Month 6 and 12	Month 6, Month 12	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.	g	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Serum P1NP at Months 6 and 12	Month 6, Month 12	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.	nanogram per milliliter (ng/mL)	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in BSAP at Months 6 and 12	Month 6, Month 12	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.	nanogram per milliliter (ng/mL)	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Serum NTX at Months 6 and 12	Month 6, Month 12	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.	nmol BCE/L	LEAST_SQUARES_MEAN
SECONDARY	Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12	Month 6, Month 12	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.	U/L	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With New Vertebral Fractures at Month 12	Month 12	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.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mean Change From Baseline in Vertebral Morphometry at Month 12	Month 12	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.	Ratio	LEAST_SQUARES_MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group47

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12	Zoledronic Acid		0.582	Standard Error 0.1279	Z-score
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12	Placebo		0.168	Standard Error 0.1449	Z-score
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6	Zoledronic Acid		0.447	Standard Error 0.13	Z-score
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6	Placebo		0.157	Standard Error 0.14	Z-score
Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12	Zoledronic Acid	Lumbar Spine (LS) BMC Change at Month 6	4.110	Standard Error 0.63	g
Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12	Placebo	Lumbar Spine (LS) BMC Change at Month 6	2.131	Standard Error 0.70	g
Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12	Zoledronic Acid	Lumbar Spine (LS) BMC Change at Month 12	6.450	Standard Error 1.18	g
Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12	Placebo	Lumbar Spine (LS) BMC Change at Month 12	4.295	Standard Error 1.32	g
Mean Change From Baseline in Total Body BMC at Month 6 and 12	Zoledronic Acid	Total BMC Change at Month 6	129.272	Standard Error 24.23	g
Mean Change From Baseline in Total Body BMC at Month 6 and 12	Placebo	Total BMC Change at Month 6	95.214	Standard Error 28.74	g

1 to 10 of 47Source ClinicalTrials.gov

See all 47 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zoledronic Acid	18
Overall Study	STARTED	Placebo	16
Overall Study	Modified Intention-to-treat (MITT)	Zoledronic Acid	17
Overall Study	Modified Intention-to-treat (MITT)	Placebo	16
Overall Study	Safety Set	Zoledronic Acid	18
Overall Study	Safety Set	Placebo	16
Overall Study	COMPLETED	Zoledronic Acid	15
Overall Study	COMPLETED	Placebo	15
Overall Study	NOT COMPLETED	Zoledronic Acid	3
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events188

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tachycardia	Cardiac disorders	Zoledronic Acid	3	18
other	Tachycardia	Cardiac disorders	Placebo	0	16
other	Adrenal insufficiency	Endocrine disorders	Zoledronic Acid	3	18
other	Adrenal insufficiency	Endocrine disorders	Placebo	0	16
other	Dry eye	Eye disorders	Zoledronic Acid	0	18
other	Dry eye	Eye disorders	Placebo	1	16
other	Eye disorder	Eye disorders	Zoledronic Acid	0	18
other	Eye disorder	Eye disorders	Placebo	1	16
other	Eye pruritus	Eye disorders	Zoledronic Acid	0	18
other	Eye pruritus	Eye disorders	Placebo	1	16

1 to 10 of 188Source ClinicalTrials.gov

See all 188 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zoledronic Acid	0	18
Total, all-cause mortality	Placebo	0	16
Total, other adverse events	Zoledronic Acid	14	18
Total, other adverse events	Placebo	12	16
Total, serious adverse events	Zoledronic Acid	5	18
Total, serious adverse events	Placebo	1	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34228102	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Zoledronic Acid vs Placebo: Number of Participants With New Vertebral Fractures at Month 12	Trial comparisons
Zoledronic Acid vs Placebo: deaths from any cause	Trial comparisons
Zoledronic Acid vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00799266

GET https://conductscience.org/api/trials/v1/NCT00799266/results?page=2

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