Phase 3
N=47
Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia
Risperidone-induced Hyperprolactinemia
Bottom Line
View on ClinicalTrials.gov: NCT00799383 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Trabecular Bone Mineral Density in the Ultradistal Radius — 192.9; 197.2; 191.0; 194.6 mg/cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Calcium and Vitamin D (Drug); Placebo (Other)
- Age
- Pediatric · 5+ yrs
- Sex
- Male
- Sponsor
- Chadi A. Calarge
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trabecular Bone Mineral Density in the Ultradistal Radius |
192.9; 197.2; 191.0; 194.6; 195.7; 213.1 | — |
| PRIMARY Total Body Bone Mineral Content |
0.10; 0.12; 0.24; 0.23; 0.20; 0.17 | — |
| SECONDARY Bone Strength Index, mg2/mm4 |
19.8; 25.3; 21.0; 22.9; 23.1; 26.1 | — |
| SECONDARY Cortical Bone Mineral Density |
1059.6; 1063.2; 1062.8; 1060.2; 1069.3; 1058.7 | — |
| SECONDARY Cortical Thickness |
2.25; 2.34; 2.25; 2.26; 2.32; 2.34 | — |
| SECONDARY Periosteal Circumference |
30.1; 32.4; 31.2; 32.6; 31.4; 32.3 | — |
| SECONDARY Endosteal Circumference |
16.0; 17.7; 17.0; 18.4; 16.8; 17.6 | — |
| SECONDARY Polar Section Modulus |
123.8; 156.2; 134.5; 156.8; 137.2; 151.9 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT00799383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.