Counteracting Risperidone-Induced Hyperprolactinemia in Youths
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Trabecular Bone Mineral Density in the Ultradistal Radius
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Calcium and Vitamin D
Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
干预措施: Calcium and Vitamin D (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Trabecular Bone Mineral Density in the Ultradistal Radius
时间窗: 36 weeks
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.
Total Body Bone Mineral Content
时间窗: 36 weeks
Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
次要结局
- Bone Strength Index, mg2/mm4(36 weeks)
- Polar Section Modulus(36 weeks)
- Periosteal Circumference(36 weeks)
- Endosteal Circumference(36 weeks)
- Cortical Bone Mineral Density(36 weeks)
- Cortical Thickness(36 weeks)
研究者
Chadi A. Calarge
Principal Investigator
University of Iowa