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

• ClinicalTrials.gov Identifier: NCT00799383
• Recruitment Status: Completed
• First Posted: November 27, 2008
• Results First Posted: December 26, 2017
• Last Update Posted: December 26, 2017
• Sponsor: Chadi A. Calarge
• Collaborators: National Institute of Mental Health (NIMH); Children's Miracle Network
• Information provided by (Responsible Party): Chadi A. Calarge, University of Iowa

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Risperidone-induced Hyperprolactinemia	Drug: Calcium and Vitamin D; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Counteracting Risperidone-Induced Hyperprolactinemia in Youths
• Study Start Date: November 2008
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Calcium and Vitamin D; Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.	Drug: Calcium and Vitamin D; Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.; Other Name: Ca+VitD
Placebo Comparator: Placebo; Placebo	Other: Placebo

Outcome Measures

Primary Outcome Measures :

1. Trabecular Bone Mineral Density in the Ultradistal Radius [ Time Frame: 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.

2. Total Body Bone Mineral Content [ Time Frame: 36 weeks ]
   Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

Secondary Outcome Measures :

1. Bone Strength Index, mg2/mm4 [ Time Frame: 36 weeks ]
   Measured at the 4% radius site.
2. Cortical Bone Mineral Density [ Time Frame: 36 weeks ]
   This was measured at the 20% radius site.
3. Cortical Thickness [ Time Frame: 36 weeks ]
   This was measured at the 20% radius site.
4. Periosteal Circumference [ Time Frame: 36 weeks ]
   This was measured at the 20% radius site.
5. Endosteal Circumference [ Time Frame: 36 weeks ]
   This was measured at the 20% radius site.
6. Polar Section Modulus [ Time Frame: 36 weeks ]
   This was measured at the 20% radius site.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 17 Years (Child)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Iowa

The University of Iowa

Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

Chadi A. Calarge

National Institute of Mental Health (NIMH)

Children's Miracle Network

Investigators

• Principal Investigator: Chadi Calarge, M.D.; University of Iowa

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Chadi A. Calarge, Principal Investigator, University of Iowa
• ClinicalTrials.gov Identifier: NCT00799383
• Other Study ID Numbers: 200807730; K23MH085005 ( U.S. NIH Grant/Contract )
• First Posted: November 27, 2008
• Results First Posted: December 26, 2017
• Last Update Posted: December 26, 2017
• Last Verified: November 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chadi A. Calarge, University of Iowa:

Risperidone; hyperprolactinemia; children; adolescents; antipsychotics; prevention; calcium; vitamin D; Risperidone-induced hyperprolactinemia

Additional relevant MeSH terms:

Hyperprolactinemia; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Vitamin D; Calcium; Vitamins; Micronutrients; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Bone Density Conservation Agents