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

Chadi A. Calarge

Status and phase: Completed; Phase 3

Conditions: Risperidone-induced Hyperprolactinemia

Treatments: Drug: Calcium and Vitamin D; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00799383

K23MH085005 (U.S. NIH Grant/Contract)

200807730

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: Male

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

47 participants in 2 patient groups, including a placebo group

Calcium and Vitamin D

Experimental group

Description:

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

Treatment:

Drug: Calcium and Vitamin D

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo