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

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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:
Collaborators:
National Institute of Mental Health (NIMH)
Children's Miracle Network
Information provided by (Responsible Party):
Chadi A. Calarge, University of Iowa

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 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


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



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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799383


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. The University of Iowa

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chadi A. Calarge, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00799383     History of Changes
Other Study ID Numbers: 200807730
K23MH085005 ( U.S. NIH Grant/Contract )
First Posted: November 27, 2008    Key Record Dates
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
Vitamins
Vitamin D
Ergocalciferols
Calcium, Dietary
Risperidone
Calcium Carbonate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antacids
Gastrointestinal Agents