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

Primary Purpose

Risperidone-induced Hyperprolactinemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Calcium and Vitamin D

Placebo

About this trial

This is an interventional prevention trial for Risperidone-induced Hyperprolactinemia focused on measuring Risperidone, hyperprolactinemia, children, adolescents, antipsychotics, prevention, calcium, vitamin D, Risperidone-induced hyperprolactinemia

Eligibility Criteria

5 Years - 17 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males (age range: 5-17yo; inclusive), in treatment with risperidone for ≥ one year.
The participants must have two measurements of prolactin ≥ 18.4 ng/ml, obtained within a week.
IQ > 35-40 (≥ Moderate intellectual disability).
An adult parent/guardian must be available to provide consent and dispense study medication.

Exclusion Criteria:

Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain), metabolic diseases (e.g., diabetes, hypo- or hyperparathyroidism, hypo- or hyperthyroidism, growth hormone deficiency), other skeletal diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis), chronic use of drugs affecting bone metabolism (e.g., corticosteroids), and malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease), congenital disorders, or lead poisoning.
Participants receiving calcium or multivitamins in the previous three months.
A history of renal calculi and fasting random urine calcium/creatinine ratio > 0.2 or any other medical disorder that contraindicates the use of calcium or vitamin D (e.g., hypercalcemic states, hypercoagulability disorders, vitamin D toxicity, malabsorption syndrome, or hypersensitivity to vitamin D products).
Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (e.g. TSH < 10 μIU/ml (76)).
Inability to cooperate with the BMD measurements.
Bilateral wrist or forearm fractures.
Eating disorders.
Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration.
Plans to move out of State within the next 9 months.

Sites / Locations

The University of Iowa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Calcium and Vitamin D

Placebo

Arm Description

Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

Placebo

Outcomes

Primary Outcome Measures

Trabecular Bone Mineral Density in the Ultradistal Radius

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.

Total Body Bone Mineral Content

Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

Secondary Outcome Measures

Bone Strength Index, mg2/mm4

Measured at the 4% radius site.

Cortical Bone Mineral Density

This was measured at the 20% radius site.

Cortical Thickness

This was measured at the 20% radius site.

Periosteal Circumference

This was measured at the 20% radius site.

Endosteal Circumference

This was measured at the 20% radius site.

Polar Section Modulus

This was measured at the 20% radius site.

Full Information

NCT ID

NCT00799383

First Posted

November 25, 2008

Last Updated

November 29, 2017

Sponsor

Chadi A. Calarge

Collaborators

National Institute of Mental Health (NIMH), Children's Miracle Network

1. Study Identification

Unique Protocol Identification Number

NCT00799383

Brief Title

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

Official Title

Counteracting Risperidone-Induced Hyperprolactinemia in Youths

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chadi A. Calarge

Collaborators

National Institute of Mental Health (NIMH), Children's Miracle Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Risperidone-induced Hyperprolactinemia

Keywords

Risperidone, hyperprolactinemia, children, adolescents, antipsychotics, prevention, calcium, vitamin D, Risperidone-induced hyperprolactinemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Calcium and Vitamin D

Arm Type

Experimental

Arm Description

Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Calcium and Vitamin D

Other Intervention Name(s)

Ca+VitD

Intervention Description

Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Trabecular Bone Mineral Density in the Ultradistal Radius

Description

Time Frame

36 weeks

Title

Total Body Bone Mineral Content

Description

Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

Time Frame

36 weeks

Secondary Outcome Measure Information:

Title

Bone Strength Index, mg2/mm4

Description

Measured at the 4% radius site.

Time Frame

36 weeks

Title

Cortical Bone Mineral Density

Description

This was measured at the 20% radius site.

Time Frame

36 weeks

Title

Cortical Thickness

Description

This was measured at the 20% radius site.

Time Frame

36 weeks

Title

Periosteal Circumference

Description

This was measured at the 20% radius site.

Time Frame

36 weeks

Title

Endosteal Circumference

Description

This was measured at the 20% radius site.

Time Frame

36 weeks

Title

Polar Section Modulus

Description

This was measured at the 20% radius site.

Time Frame

36 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males (age range: 5-17yo; inclusive), in treatment with risperidone for ≥ one year. The participants must have two measurements of prolactin ≥ 18.4 ng/ml, obtained within a week. IQ > 35-40 (≥ Moderate intellectual disability). An adult parent/guardian must be available to provide consent and dispense study medication. Exclusion Criteria: Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain), metabolic diseases (e.g., diabetes, hypo- or hyperparathyroidism, hypo- or hyperthyroidism, growth hormone deficiency), other skeletal diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis), chronic use of drugs affecting bone metabolism (e.g., corticosteroids), and malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease), congenital disorders, or lead poisoning. Participants receiving calcium or multivitamins in the previous three months. A history of renal calculi and fasting random urine calcium/creatinine ratio > 0.2 or any other medical disorder that contraindicates the use of calcium or vitamin D (e.g., hypercalcemic states, hypercoagulability disorders, vitamin D toxicity, malabsorption syndrome, or hypersensitivity to vitamin D products). Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (e.g. TSH < 10 μIU/ml (76)). Inability to cooperate with the BMD measurements. Bilateral wrist or forearm fractures. Eating disorders. Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration. Plans to move out of State within the next 9 months.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chadi Calarge, M.D.

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

The University of Iowa

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29112461

Citation

Calarge CA, Mills JA, Ziegler EE, Schlechte JA. Calcium and Vitamin D Supplementation in Boys with Risperidone-Induced Hyperprolactinemia: A Randomized, Placebo-Controlled Pilot Study. J Child Adolesc Psychopharmacol. 2018 Mar;28(2):145-150. doi: 10.1089/cap.2017.0104. Epub 2017 Nov 7.

Results Reference

derived

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

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