Clinical trial NCT00799383: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Risperidone-induced Hyperprolactinemia
Keywords: Risperidone
hyperprolactinemia
children
adolescents
antipsychotics
prevention
calcium
vitamin D
Risperidone-induced hyperprolactinemia
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Children's Miracle Network
First posted: 2008-11-27
Enrollment: 47
Sex: MALE
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Participants receiving calcium or multivitamins in the previous three months.
3. 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).
4. Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (e.g. TSH \< 10 μIU/ml (76)).
5. Inability to cooperate with the BMD measurements.
6. Bilateral wrist or forearm fractures.
7. Eating disorders.
8. Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration.
9. Plans to move out of State within the next 9 months.

Primary outcomes:
measure: Trabecular Bone Mineral Density in the Ultradistal Radius
timeFrame: 36 weeks
measure: Total Body Bone Mineral Content
timeFrame: 36 weeks
Secondary outcomes:
measure: Bone Strength Index, mg2/mm4
timeFrame: 36 weeks
measure: Cortical Bone Mineral Density
timeFrame: 36 weeks
measure: Cortical Thickness
timeFrame: 36 weeks
measure: Periosteal Circumference
timeFrame: 36 weeks
measure: Endosteal Circumference
timeFrame: 36 weeks
measure: Polar Section Modulus
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Chadi Calarge, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.