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

Study Overview
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Brief Summary
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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.

Official Title
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Counteracting Risperidone-Induced Hyperprolactinemia in Youths

Conditions
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Risperidone-induced Hyperprolactinemia

Intervention / Treatment
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* Drug: Calcium and Vitamin D
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Calcium and Vitamin D<br>Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. | Drug: Calcium and Vitamin D<br>* Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.<br>* Other names: Ca+VitD;|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 36 weeks | 
| Total Body Bone Mineral Content | Outcomes were measured at baseline, 18 weeks, and 36 weeks later. | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Strength Index, mg2/mm4 | Measured at the 4% radius site. | 36 weeks | 
| Cortical Bone Mineral Density | This was measured at the 20% radius site. | 36 weeks | 
| Cortical Thickness | This was measured at the 20% radius site. | 36 weeks | 
| Periosteal Circumference | This was measured at the 20% radius site. | 36 weeks | 
| Endosteal Circumference | This was measured at the 20% radius site. | 36 weeks | 
| Polar Section Modulus | This was measured at the 20% radius site. | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risperidone, hyperprolactinemia, children, adolescents, antipsychotics, prevention, calcium, vitamin D, Risperidone-induced hyperprolactinemia