Risperidone-induced Hyperprolactinemia Clinical Trial
Official title:
Counteracting Risperidone-Induced Hyperprolactinemia in Youths
| Verified date | November 2017 |
| Source | University of Iowa |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 47 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 5 Years to 17 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Iowa | Iowa City | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Chadi A. Calarge | Children's Miracle Network, National Institute of Mental Health (NIMH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Total Body Bone Mineral Content | Outcomes were measured at baseline, 18 weeks, and 36 weeks later. | 36 weeks | |
| Secondary | Bone Strength Index, mg2/mm4 | Measured at the 4% radius site. | 36 weeks | |
| Secondary | Cortical Bone Mineral Density | This was measured at the 20% radius site. | 36 weeks | |
| Secondary | Cortical Thickness | This was measured at the 20% radius site. | 36 weeks | |
| Secondary | Periosteal Circumference | This was measured at the 20% radius site. | 36 weeks | |
| Secondary | Endosteal Circumference | This was measured at the 20% radius site. | 36 weeks | |
| Secondary | Polar Section Modulus | This was measured at the 20% radius site. | 36 weeks |