Trial · NCT00799383

Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia

NCT00799383, Phase 3, Completed, Chadi A. Calarge; results first posted 2017-12-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia. Trials, record NCT00799383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00799383

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Trial

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

Title: Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia
NCT number: NCT00799383
Status: Completed
Phases: Phase 3
Enrollment: 47 participants, actual
Lead sponsor: Chadi A. Calarge
Conditions: Risperidone-induced Hyperprolactinemia
Interventions: Calcium and Vitamin D, Placebo
First posted: 2008-11-27
Last updated: 2017-12-26
Results first posted: 2017-12-26
Limitations and caveats: Failure to enroll vitamin D deficient patients. The supplements dose were modest. The sample size was small. We may have included too broad a pubertal stage. We did not supplement other micronutrients. We did not include females.

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Trabecular Bone Mineral Density in the Ultradistal Radius	36 weeks	Peripheral quantitative computed tomography (pQCT) scan was obtained at the 4% and 20% sites of the nondominant radius to estimate trabecular and cortical BMD, respectively. A Stratec XCT-2000 scanner, software version 6.0 (Stratec, Inc., Pforzheim, Germany),was used. Trabecular BMD was measured as the mean density of the 85% central area of the bone's cross-section. Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
Primary	Total Body Bone Mineral Content	36 weeks	Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
Secondary	Bone Strength Index, mg2/mm4	36 weeks	Measured at the 4% radius site.
Secondary	Cortical Bone Mineral Density	36 weeks	This was measured at the 20% radius site.
Secondary	Cortical Thickness	36 weeks	This was measured at the 20% radius site.
Secondary	Periosteal Circumference	36 weeks	This was measured at the 20% radius site.
Secondary	Endosteal Circumference	36 weeks	This was measured at the 20% radius site.
Secondary	Polar Section Modulus	36 weeks	This was measured at the 20% radius site.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Trabecular Bone Mineral Density in the Ultradistal Radius	36 weeks	The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded. At late time points, the sample size reflects both attrition and exclusion due to movement artifact.	mg/cm^3	MEAN
PRIMARY	Total Body Bone Mineral Content	36 weeks	Numbers below reflect attrition.	Z score (age-sex-height-race specific)	MEAN
SECONDARY	Bone Strength Index, mg2/mm4	36 weeks	Sample size is smaller because scans with movement artifact were removed at baseline. At follow up, attrition also contributed.	mg^2/mm^4	MEAN
SECONDARY	Cortical Bone Mineral Density	36 weeks	Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.	mg/cm^3	MEAN
SECONDARY	Cortical Thickness	36 weeks	Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.	mm	MEAN
SECONDARY	Periosteal Circumference	36 weeks	Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.	mm	MEAN
SECONDARY	Endosteal Circumference	36 weeks	Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.	mm	MEAN
SECONDARY	Polar Section Modulus	36 weeks	Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.	mm^3	MEAN

Source ClinicalTrials.gov

Results by group48

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

Outcome	Group	Category	Value	Spread	Units
Trabecular Bone Mineral Density in the Ultradistal Radius	Calcium+VitD	Baseline	192.9	Standard Deviation 31.1	mg/cm^3
Trabecular Bone Mineral Density in the Ultradistal Radius	Placebo	Baseline	197.2	Standard Deviation 43.9	mg/cm^3
Trabecular Bone Mineral Density in the Ultradistal Radius	Calcium+VitD	At 18 Weeks	191.0	Standard Deviation 38.4	mg/cm^3
Trabecular Bone Mineral Density in the Ultradistal Radius	Placebo	At 18 Weeks	194.6	Standard Deviation 41.2	mg/cm^3
Trabecular Bone Mineral Density in the Ultradistal Radius	Calcium+VitD	At 36 Weeks	195.7	Standard Deviation 36.9	mg/cm^3
Trabecular Bone Mineral Density in the Ultradistal Radius	Placebo	At 36 Weeks	213.1	Standard Deviation 42.1	mg/cm^3
Total Body Bone Mineral Content	Calcium+VitD	At Baseline	0.10	Standard Deviation 0.79	Z score (age-sex-height-race specific)
Total Body Bone Mineral Content	Placebo	At Baseline	0.12	Standard Deviation 0.68	Z score (age-sex-height-race specific)
Total Body Bone Mineral Content	Calcium+VitD	At 18 Weeks	0.24	Standard Deviation 0.81	Z score (age-sex-height-race specific)
Total Body Bone Mineral Content	Placebo	At 18 Weeks	0.23	Standard Deviation 0.76	Z score (age-sex-height-race specific)

1 to 10 of 48Source ClinicalTrials.gov

See all 48 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Calcium+VitD	23
Overall Study	STARTED	Placebo	24
Overall Study	COMPLETED	Calcium+VitD	20
Overall Study	COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	Calcium+VitD	3
Overall Study	NOT COMPLETED	Placebo	6

Source ClinicalTrials.gov

Adverse events14

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	Events
other	Stomach ache	Gastrointestinal disorders	Calcium+VitD	5	23	5
other	Stomach ache	Gastrointestinal disorders	Placebo	3	24	3
other	Bloating	Gastrointestinal disorders	Calcium+VitD	1	23	1
other	Bloating	Gastrointestinal disorders	Placebo	0	24	0
other	Nausea/Vomiting	Gastrointestinal disorders	Calcium+VitD	4	23	4
other	Nausea/Vomiting	Gastrointestinal disorders	Placebo	0	24	0
other	Diarrhea	Gastrointestinal disorders	Calcium+VitD	2	23	2
other	Diarrhea	Gastrointestinal disorders	Placebo	1	24	1
other	Constipation	Gastrointestinal disorders	Calcium+VitD	5	23	5
other	Constipation	Gastrointestinal disorders	Placebo	3	24	3

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Calcium+VitD	0	23
Total, all-cause mortality	Placebo	0	24
Total, other adverse events	Calcium+VitD	11	23
Total, other adverse events	Placebo	8	24
Total, serious adverse events	Calcium+VitD	0	23
Total, serious adverse events	Placebo	0	24

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29112461	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
K23MH085005	Counteracting Risperidone-Induced Hyperprolactinemia in Youths	CALARGE, CHADI A.	UNIVERSITY OF IOWA	NATIONAL INSTITUTE OF MENTAL HEALTH	2009 to 2013

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Calcium+VitD vs Placebo: deaths from any cause	Trial comparisons
Calcium+VitD 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.

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