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

NCT00799383 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 200807730K23MH085005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Risperidone-induced Hyperprolactinemia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Total Body Bone Mineral Content

  Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

  36 weeks

Secondary Outcomes (6)

• Bone Strength Index, mg2/mm4

  36 weeks

• Cortical Bone Mineral Density

  36 weeks

• Cortical Thickness

  36 weeks

• Periosteal Circumference

  36 weeks

• Endosteal Circumference

  36 weeks

Study Arms (2)

Calcium and Vitamin D

EXPERIMENTAL

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

Drug: Calcium and Vitamin D

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Calcium and Vitamin D DRUG

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

Also known as: Ca+VitD

Calcium and Vitamin D

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chadi A. Calarge: lead
• National Institute of Mental Health (NIMH): collaborator
• Children's Miracle Network: collaborator

Study Sites (1)

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 29112461 DERIVED

MeSH Terms

Conditions

Hyperprolactinemia

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Failure to enroll vitamin D deficient patients. The supplements dose were modest. The sample size was small. We may have included too broad a pubertal stage. We did not supplement other micronutrients. We did not include females.

Results Point of Contact

• Title: Chadi Calarge, MD
• Organization: Baylor College of Medicine

chadi.calarge@bcm.edu

832-824-4764

Study Officials

• Chadi Calarge, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 27, 2008
• Study Start: November 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: December 26, 2017
• Results First Posted: December 26, 2017

Record last verified: 2017-11

Locations

US (1)