Risperidone-induced HyperprolactinemiaPhase 3NCT00799383

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

A Phase 3 study testing Calcium and Vitamin D in people with Risperidone-induced Hyperprolactinemia, run by Chadi A. Calarge at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 5 to 17 years, men only
Conditions the study is for: Risperidone-induced Hyperprolactinemia
What is being tested?: Calcium and Vitamin D
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 47 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Mar 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 17 years
Men only
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Iowa
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Counteracting Risperidone-Induced Hyperprolactinemia in Youths

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
Being tested: Calcium and Vitamin D, Placebo
Keywords: Risperidone, hyperprolactinemia, children, adolescents, antipsychotics, prevention, calcium, vitamin D, Risperidone-induced hyperprolactinemia
Medical subject headings: Hyperprolactinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Calcium and Vitamin DDrug
Also called Ca+VitD
Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
PlaceboOther

Study groups in NCT00799383
Study group	Role	What they receive
Calcium and Vitamin D	Experimental	Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. Receives: Drug: Calcium and Vitamin D
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 36 weeks
Total Body Bone Mineral Content
Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
Measured: 36 weeks

Secondary outcomes (6)

Bone Strength Index, mg2/mm4
Measured at the 4% radius site.
Measured: 36 weeks
Cortical Bone Mineral Density
This was measured at the 20% radius site.
Measured: 36 weeks
Cortical Thickness
This was measured at the 20% radius site.
Measured: 36 weeks
Periosteal Circumference
This was measured at the 20% radius site.
Measured: 36 weeks
Endosteal Circumference
This was measured at the 20% radius site.
Measured: 36 weeks
Polar Section Modulus
This was measured at the 20% radius site.
Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Mar 2014

First posted27 Nov 2008 (estimated)
Study startNov 2008
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Risperidone-induced HyperprolactinemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00799383
Sponsor's protocol ID: 200807730
Other IDs: K23MH085005
Status last verified: Nov 2017
First submitted: 25 Nov 2008
Last updated: 26 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 29112461

Study at a glance

From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Counteracting Risperidone-Induced Hyperprolactinemia in Youths
ClinicalTrials.gov ID: NCT00799383
Acronym / sponsor ID: 200807730
Conditions: Risperidone-induced Hyperprolactinemia
Keywords: Risperidone, hyperprolactinemia, children, adolescents, antipsychotics, prevention, calcium, vitamin D
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: Chadi A. CalargeUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Children's Miracle Network
Study start: Nov 2008
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 27 Nov 2008 (estimated)
Results: Posted 26 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Calcium and Vitamin D	Experimental	Drug: Calcium and Vitamin DCalcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 5 to 17 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Calcium and Vitamin DAlso: Ca+VitDCalcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.	Drug	Calcium and Vitamin D
Placebo	Other	Placebo

Primary outcome

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.
Total Body Bone Mineral Content
Time frame: 36 weeks
Outcomes were measured at baseline, 18 weeks, and 36 weeks later.

6 secondary outcomes

Bone Strength Index, mg2/mm4
Time frame: 36 weeks
Cortical Bone Mineral Density
Time frame: 36 weeks
Cortical Thickness
Time frame: 36 weeks
Periosteal Circumference
Time frame: 36 weeks
Endosteal Circumference
Time frame: 36 weeks
Polar Section Modulus
Time frame: 36 weeks

Results and safety

Results posted to the registry on 26 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Calcium+VitD	23	20
Placebo	24	18

Primary outcome: Trabecular Bone Mineral Density in the Ultradistal Radius

Time frame: 36 weeks. Mean (Standard Deviation). Unit: mg/cm^3

Measure	Calcium+VitD n = 22	Placebo n = 21
Baseline	192.9 (31.1)	197.2 (43.9)
At 18 Weeks	191.0 (38.4)	194.6 (41.2)
At 36 Weeks	195.7 (36.9)	213.1 (42.1)

Population analysed: The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded. At late time points, the sample size reflects both attrition and exclusion due to movement artifact.

Primary outcome: Total Body Bone Mineral Content

Time frame: 36 weeks. Mean (Standard Deviation). Unit: Z score (age-sex-height-race specific)

Measure	Calcium+VitD n = 23	Placebo n = 24
At Baseline	0.10 (0.79)	0.12 (0.68)
At 18 Weeks	0.24 (0.81)	0.23 (0.76)
At 36 Weeks	0.20 (0.86)	0.17 (0.78)

Population analysed: Numbers below reflect attrition.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data collected during 36 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Calcium+VitD	0 of 23 (0%)	11 of 23 (47.8%)	0 of 23
Placebo	0 of 24 (0%)	8 of 24 (33.3%)	0 of 24

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29112461Calarge 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chadi Calarge, M.D. principal investigator

University of Iowa

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Calcium and Vitamin D in people with Risperidone-induced Hyperprolactinemia, run by Chadi A. Calarge at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trabecular Bone Mineral Density in the Ultradistal Radius (time frame: 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00799383, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.