Trial Outcomes & Findings for Growth Hormone Therapy in Osteogenesis Imperfecta (NCT NCT00001305)

Last Updated: 2019-01-29

Results Overview

The proportion of subjects who met the study criteria of at least 50% increase in growth rate since baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

42 participants

Primary outcome timeframe

1 year

Results posted on

2019-01-29

Participant milestones
Measure	Growth Hormone Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
Overall Study STARTED	42
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Growth Hormone Therapy in Osteogenesis Imperfecta

Baseline characteristics by cohort
Measure	Growth Hormone n=42 Participants Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
Age, Categorical <=18 years	42 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

Timeframe: 1 year

Population: The analyses included only those subjects who completed 1 year of study

The proportion of subjects who met the study criteria of at least 50% increase in growth rate since baseline.

Outcome measures
Measure	Growth Hormone n=42 Participants Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
Proportion of Subjects Who Met Criteria of Increase in Growth Rate Since Baseline.	25 Participants

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events
Measure	Growth Hormone n=42 participants at risk Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
Psychiatric disorders Suicide attempt	2.4% 1/42 • Number of events 1 • 1 year

Other adverse events
Measure	Growth Hormone n=42 participants at risk Treatment of children with types III and IV Osteogenesis Imperfecta with Growth Hormone Humatrope 0.06 mg/kg/day, 6 of 7 days per week
Nervous system disorders Headache	7.1% 3/42 • Number of events 3 • 1 year
Immune system disorders Reaction to preservatives	2.4% 1/42 • Number of events 1 • 1 year

National Institute of Child Health and Human Development

Phone: +1 301 594 3418