Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm

NCTNCT00163189Other idA6281271Other id2004-002992-17Other id2004

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 98 participants (actual)
Sponsor: Pfizer · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
France
Start: Jan 2005
Primary completion: Dec 2014
Completion: Dec 2014
First posted: 13 Sept 2005 (estimated)
Last update posted: 21 Feb 2024
Conditions: Growth Hormone Deficiency

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062008201020122014

Ph 3
Evolution Of Growth Rate In Children With Growth Retardation Due to Glucocorticosteroid Therapy And Treated By Genotonorm
NCT00163189
Jan 2005 to Dec 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To estimate the evolution of height and growth rate over 5 years of growth hormone (GH) treatment To estimate the prognostic factors of growth rate with GH treatment To confirm the good clinical and biological safety of GH treatment in such children

Interventions

SomatropinDrug

Arms1

Experimental
Somatropin

Primary outcomes2

Outcomes the sponsor listed as primary.

Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population
Time frame · Baseline, Month 36
Registry description
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Change From Baseline in Height Standard Deviation Score (SD) for Chronological Age (CA) at Month 36: Per Protocol (PP) Population
Time frame · Baseline, Month 36
Registry description
Height was measured using a wall mounted device (example, Harpenden stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.

Secondary outcomes(11)

Mean Height
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.
Mean Height Standard Deviation Score (SDS) for Bone Age (BA)
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.
Annual Growth Rate (AGR)
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
AGR at Yx was derived by subtracting AGR at baseline from Yx value. AGR was calculated each year and re scaled to 1 year if the interval between Yx and Y\[x-1\] was not 365 days, as long as a participant remained in the study. AGR at Yx was calculated using the previous height measurements (Y\[x-1\]) and height recorded at Yx (AGR Yx = \[height Yx-height Y{x-1}\] / (\[date of Yx - date of Y{x-1}\] /365.25). Yx refers to the value at particular timepoint x.
Growth Rate (GR) Standard Deviation Score (SDS) for Bone Age (BA)
Time frame · Month 12, 24, 36, 48, 60
Registry description
GR SDS BA Yx = (GR Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. BA was estimated locally using an X-ray from the left wrist and hand.
Growth Rate (GR) Standard Deviation Score (SDS) for Chronological Age (CA)
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
GR SDS CA Yx = (GR Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. GR in SDS was calculated using Sempe reference means and SD for GR. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Body Mass Index (BMI)
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2).
Change From Baseline in Height at Month 12, 24, 36, 48 and 60
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded.
Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 12, 24, 48 and 60
Time frame · Baseline, Month 12, 24, 48, 60
Registry description
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS CA Yx = (height Yx - reference mean for CA Yx) / reference SD for CA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. CA calculated as integer (Date of height measurement-Date of birth)/365.25\*12.
Change From Baseline in Height Standard Deviation Score (SDS) for Bone Age (BA) at Month 12, 24, 36, 48 and 60
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
The standing height measurements were performed using a wall mounted device (example Harpenden Stadiometer). The standing height of the participant was measured two times and the mean of these measurements was recorded. Height SDS BA Yx = (height Yx - reference mean for BA Yx) / reference SD for BA Yx; Yx refers to the value at particular timepoint x. Height in SDS was calculated using Sempe reference means and SD for height. BA was estimated locally using an X-ray from the left wrist and hand.
Change From Baseline in Bone Age (BA) at Month 12, 24, 36, 48 and 60
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
BA was estimated locally using an X-ray from the left wrist and hand.
Ratio of Bone Age (BA) to Chronological Age (CA)
Time frame · Baseline, Month 12, 24, 36, 48, 60
Registry description
BA was estimated locally using an X-ray from the left wrist and hand. CA at the date of corresponding X-ray (Date of X-ray - Date of birth)/365.25. Ratio of BA/CA at each annual study visit was calculated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, Month 36

Change From Baseline in Height Standard Deviation Score (SDS) for Chronological Age (CA) at Month 36: Full Analysis Population

Group	Value (Standard Deviation Score (SDS))	Spread
Genotonorm	-2.91	1.19

Primary outcomeMean· Baseline, Month 36