Trial Outcomes & Findings for Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia (NCT NCT00799383)
NCT ID: NCT00799383
Last Updated: 2017-12-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
47 participants
Primary outcome timeframe
36 weeks
Results posted on
2017-12-26
Participant Flow
Between 02/2009 and 11/2013, medically-healthy 5 to 17 year-old risperidone-treated boys were enrolled, via screening of the electronic medical records, referrals, and word of mouth.
Participants were required to have been in treatment with risperidone for at least one year. They should have had a prolactin concentration ≥ 18.4 ng/ml on two occasions, within one week.
Participant milestones
| Measure |
Calcium+VitD
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
|
Placebo
Placebo administered in similarly looking capsules.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
COMPLETED
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Calcium+VitD
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
|
Placebo
Placebo administered in similarly looking capsules.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Urinary Calcium/Creatinine > 0.2
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded
Baseline characteristics by cohort
| Measure |
Calcium+VitD
n=23 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=24 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 3.0 • n=23 Participants
|
12.1 years
STANDARD_DEVIATION 3.0 • n=24 Participants
|
11.5 years
STANDARD_DEVIATION 3.0 • n=47 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=23 Participants
|
24 Participants
n=24 Participants
|
47 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=23 Participants
|
24 Participants
n=24 Participants
|
45 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=23 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=23 Participants
|
19 Participants
n=24 Participants
|
40 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=23 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=47 Participants
|
|
Total Body Less Head Bone Mineral Content Z-score
|
0.10 Z-score
STANDARD_DEVIATION 0.79 • n=23 Participants
|
0.12 Z-score
STANDARD_DEVIATION 0.68 • n=24 Participants
|
0.11 Z-score
STANDARD_DEVIATION 0.73 • n=47 Participants
|
|
Trabecular Bone Mineral Density, mg/cm3
|
192.9 mg/cm3
STANDARD_DEVIATION 31.1 • n=22 Participants • The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded
|
197.2 mg/cm3
STANDARD_DEVIATION 43.9 • n=21 Participants • The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded
|
195.0 mg/cm3
STANDARD_DEVIATION 37.5 • n=43 Participants • The number at baseline is smaller than the randomized number because bone scans with movement artifact were discarded
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Calcium+VitD
n=22 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=21 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Trabecular Bone Mineral Density in the Ultradistal Radius
Baseline
|
192.9 mg/cm^3
Standard Deviation 31.1
|
197.2 mg/cm^3
Standard Deviation 43.9
|
|
Trabecular Bone Mineral Density in the Ultradistal Radius
At 18 Weeks
|
191.0 mg/cm^3
Standard Deviation 38.4
|
194.6 mg/cm^3
Standard Deviation 41.2
|
|
Trabecular Bone Mineral Density in the Ultradistal Radius
At 36 Weeks
|
195.7 mg/cm^3
Standard Deviation 36.9
|
213.1 mg/cm^3
Standard Deviation 42.1
|
PRIMARY outcome
Timeframe: 36 weeksPopulation: Numbers below reflect attrition.
Outcomes were measured at baseline, 18 weeks, and 36 weeks later.
Outcome measures
| Measure |
Calcium+VitD
n=23 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=24 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Total Body Bone Mineral Content
At Baseline
|
0.10 Z score (age-sex-height-race specific)
Standard Deviation 0.79
|
0.12 Z score (age-sex-height-race specific)
Standard Deviation 0.68
|
|
Total Body Bone Mineral Content
At 18 Weeks
|
0.24 Z score (age-sex-height-race specific)
Standard Deviation 0.81
|
0.23 Z score (age-sex-height-race specific)
Standard Deviation 0.76
|
|
Total Body Bone Mineral Content
At 36 Weeks
|
0.20 Z score (age-sex-height-race specific)
Standard Deviation 0.86
|
0.17 Z score (age-sex-height-race specific)
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Sample size is smaller because scans with movement artifact were removed at baseline. At follow up, attrition also contributed.
Measured at the 4% radius site.
Outcome measures
| Measure |
Calcium+VitD
n=22 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=21 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Bone Strength Index, mg2/mm4
Baseline
|
19.8 mg^2/mm^4
Standard Deviation 8.1
|
25.3 mg^2/mm^4
Standard Deviation 15.9
|
|
Bone Strength Index, mg2/mm4
week 18
|
21.0 mg^2/mm^4
Standard Deviation 9.1
|
22.9 mg^2/mm^4
Standard Deviation 14.3
|
|
Bone Strength Index, mg2/mm4
week 36
|
23.1 mg^2/mm^4
Standard Deviation 9.6
|
26.1 mg^2/mm^4
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.
This was measured at the 20% radius site.
Outcome measures
| Measure |
Calcium+VitD
n=18 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=20 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Cortical Bone Mineral Density
Baseline
|
1059.6 mg/cm^3
Standard Deviation 34.8
|
1063.2 mg/cm^3
Standard Deviation 30.6
|
|
Cortical Bone Mineral Density
week 18
|
1062.8 mg/cm^3
Standard Deviation 34.5
|
1060.2 mg/cm^3
Standard Deviation 27.1
|
|
Cortical Bone Mineral Density
week 36
|
1069.3 mg/cm^3
Standard Deviation 31.8
|
1058.7 mg/cm^3
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.
This was measured at the 20% radius site.
Outcome measures
| Measure |
Calcium+VitD
n=18 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=20 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Cortical Thickness
Baseline
|
2.25 mm
Standard Deviation 0.32
|
2.34 mm
Standard Deviation 0.50
|
|
Cortical Thickness
week 18
|
2.25 mm
Standard Deviation 0.34
|
2.26 mm
Standard Deviation 0.45
|
|
Cortical Thickness
week 36
|
2.32 mm
Standard Deviation 0.35
|
2.34 mm
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.
This was measured at the 20% radius site.
Outcome measures
| Measure |
Calcium+VitD
n=18 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=20 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Periosteal Circumference
Baseline
|
30.1 mm
Standard Deviation 4.3
|
32.4 mm
Standard Deviation 5.4
|
|
Periosteal Circumference
week 18
|
31.2 mm
Standard Deviation 4.3
|
32.6 mm
Standard Deviation 6.1
|
|
Periosteal Circumference
week 36
|
31.4 mm
Standard Deviation 4.0
|
32.3 mm
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.
This was measured at the 20% radius site.
Outcome measures
| Measure |
Calcium+VitD
n=18 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=20 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Endosteal Circumference
Baseline
|
16.0 mm
Standard Deviation 3.4
|
17.7 mm
Standard Deviation 3.6
|
|
Endosteal Circumference
week 18
|
17.0 mm
Standard Deviation 3.9
|
18.4 mm
Standard Deviation 5.1
|
|
Endosteal Circumference
week 36
|
16.8 mm
Standard Deviation 3.7
|
17.6 mm
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: Sample size reduced due to exclusion of scans with movement artifact and, in later visits, due to attrition as well.
This was measured at the 20% radius site.
Outcome measures
| Measure |
Calcium+VitD
n=18 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=20 Participants
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Polar Section Modulus
Baseline
|
123.8 mm^3
Standard Deviation 53.6
|
156.2 mm^3
Standard Deviation 76.6
|
|
Polar Section Modulus
week 18
|
134.5 mm^3
Standard Deviation 55.1
|
156.8 mm^3
Standard Deviation 91.9
|
|
Polar Section Modulus
week 36
|
137.2 mm^3
Standard Deviation 49.2
|
151.9 mm^3
Standard Deviation 75.6
|
Adverse Events
Calcium+VitD
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Calcium+VitD
n=23 participants at risk
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
Placebo
n=24 participants at risk
Calcium and Vitamin D: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
I labelled the intervention type as "drug", even though "dietary supplement" would be more appropriate as the system sent the following error message:
ERROR: An IND/IDE study must have at least one intervention of type: Drug, Device, Biological/Vaccine, Radiation or Genetic.
|
|---|---|---|
|
Gastrointestinal disorders
Stomach ache
|
21.7%
5/23 • Number of events 5 • Data collected during 36 weeks.
|
12.5%
3/24 • Number of events 3 • Data collected during 36 weeks.
|
|
Gastrointestinal disorders
Bloating
|
4.3%
1/23 • Number of events 1 • Data collected during 36 weeks.
|
0.00%
0/24 • Data collected during 36 weeks.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
17.4%
4/23 • Number of events 4 • Data collected during 36 weeks.
|
0.00%
0/24 • Data collected during 36 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
2/23 • Number of events 2 • Data collected during 36 weeks.
|
4.2%
1/24 • Number of events 1 • Data collected during 36 weeks.
|
|
Gastrointestinal disorders
Constipation
|
21.7%
5/23 • Number of events 5 • Data collected during 36 weeks.
|
12.5%
3/24 • Number of events 3 • Data collected during 36 weeks.
|
|
Renal and urinary disorders
Urinary calcium/Creatinine Ratio
|
4.3%
1/23 • Number of events 1 • Data collected during 36 weeks.
|
4.2%
1/24 • Number of events 1 • Data collected during 36 weeks.
|
|
Psychiatric disorders
Increased energy
|
0.00%
0/23 • Data collected during 36 weeks.
|
4.2%
1/24 • Number of events 1 • Data collected during 36 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place