Trial · NCT00266656

Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

NCT00266656, Phase 4, Completed, Eli Lilly and Company; results first posted 2016-08-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome. Trials, record NCT00266656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00266656

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
NCT number: NCT00266656
Status: Completed
Phases: Phase 4
Enrollment: 69 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Turner Syndrome
Interventions: Humatrope
First posted: 2005-12-19
Last updated: 2017-03-31
Results first posted: 2016-08-23

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Most Mature Height Standard Deviation Score (SDS)	Baseline through End of Study (10 years)	SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Secondary	Height SDS at Various Ages	Age 10, Age 13, Age 16	SDS reports the number of standard deviations from the mean for age and sex for an individual measurement (normal range is -2 to +2 SDS). Height SDS is derived by subtracting the population mean from individual's height value and then dividing that difference by the population standard deviation. Greater height SDS values indicate greater height.
Secondary	Age at Attainment of Tanner 2 Breast Development	Baseline through End of Study (10 years)	The Tanner 2 breast development is the age at first evidence of breast development.
Secondary	Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years	Baseline through End of Study (10 years)	Bone age was measured by standard radiograph, x-ray at baseline and annually for 10 years or until attainment of height velocity less than or equal to 1.0 centimeter per year (cm/year) and bone age greater or equal to 15 years.
Secondary	Reports of Serious Adverse Events	Baseline through End of Study (10 years)	Number of serious adverse events (SAEs) reported. Any adverse event from this study that results in one of the following outcomes, or is significant for any other reason were reported as an SAE: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a study subject, significant for any other reason (includes cancer, other than superficial, and basal cell or squamous cell carcinomas of the skin, that did not meet other serious adverse event criteria). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Secondary	Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events	Baseline through End of Study (10 years)	Percentage of participants for whom certain non-serious, pre-specified adverse events (AEs; those that are commonly observed in Turner syndrome or are known to be related to GH treatment: impaired glucose tolerance, diabetes mellitus, hypothyroidism, benign intracranial hypertension, scoliosis, slipped capital femoral epiphysis, solid tumor/leukemia, pancreatitis, ear infections, and high blood pressure) are reported.
Secondary	Percentage of Participants With Abnormal Tympanometry Results	Baseline, Age 10, Age 16, End of Study (10 years)	Percentage of participants with abnormal tympanometry \[defined as middle ear dysfunction / middle ear effusion / patent pressure equalizer tube or possible tympanic membrane perforation\] results at baseline, age 10 years, and age 16 years or endpoint.
Secondary	Percentage of Participants With Prevalence of Abnormal Audiometry Results	Baseline, Age 10, Age 16, End of Study (10 years)	Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. Prevalence was calculated as number of participants with abnormal hearing divided by number of participants with measurable pure tone audiometry results at that visit.
Secondary	Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)	Baseline, Age 10, Age 16, End of Study (10 years)	Percentage of participants with abnormal Audiometry results at baseline, age 10 years, and age 16 years or endpoint. PTA is defined as the average of pure tone hearing thresholds at 500, 1000 and 2000 Hz (Hertz), calculated separately for each ear and for each testing method (air or bone); normal PTA is defined as pure tone hearing threshold less than or equal to 20 dB HL (decibels Hearing Level), and abnormal PTA is defined as pure tone hearing threshold greater than 20 DB HL.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Most Mature Height Standard Deviation Score (SDS)	Baseline through End of Study (10 years)	All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.	standard deviation score	MEAN
SECONDARY	Height SDS at Various Ages	Age 10, Age 13, Age 16	All participants who had a baseline visit and at least one post-baseline visit.	Standard deviation score	MEAN
SECONDARY	Age at Attainment of Tanner 2 Breast Development	Baseline through End of Study (10 years)	All participants who had a baseline visit and at least one post-baseline visit.	years	MEAN
SECONDARY	Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years	Baseline through End of Study (10 years)	All participants who achieved Near Adult Height (NAH). NAH is defined as first height measured when height velocity is less than or equal to 2.0 centimeter per year over the preceding year (in the absence of growth-impairing process such as hypothyroidism or inflammatory bowel disease), or bone age greater than or equal to14.5 years.	years	MEAN
SECONDARY	Reports of Serious Adverse Events	Baseline through End of Study (10 years)	All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.	events	NUMBER
SECONDARY	Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events	Baseline through End of Study (10 years)	All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Abnormal Tympanometry Results	Baseline, Age 10, Age 16, End of Study (10 years)	All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Prevalence of Abnormal Audiometry Results	Baseline, Age 10, Age 16, End of Study (10 years)	All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA)	Baseline, Age 10, Age 16, End of Study (10 years)	All participants who had a baseline visit, regardless of whether or not they received Humatrope at any time.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group182

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Most Mature Height Standard Deviation Score (SDS)	Early Treated		-1.37	Standard Deviation 1.09	standard deviation score
Most Mature Height Standard Deviation Score (SDS)	Early Untreated		-1.60	Standard Deviation 1.21	standard deviation score
Height SDS at Various Ages	Early Treated	Age 10 (n=32, 30)	-0.66	Standard Deviation 1.16	Standard deviation score
Height SDS at Various Ages	Early Untreated	Age 10 (n=32, 30)	-1.28	Standard Deviation 1.17	Standard deviation score
Height SDS at Various Ages	Early Treated	Age 13 (n=29, 29)	-1.29	Standard Deviation 1.24	Standard deviation score
Height SDS at Various Ages	Early Untreated	Age 13 (n=29, 29)	-1.87	Standard Deviation 1.16	Standard deviation score
Height SDS at Various Ages	Early Treated	Age 16 (n=18, 18)	-1.66	Standard Deviation 1.11	Standard deviation score
Height SDS at Various Ages	Early Untreated	Age 16 (n=18, 18)	-1.69	Standard Deviation 1.30	Standard deviation score
Age at Attainment of Tanner 2 Breast Development	Early Treated		11.80	Standard Error 0.26	years
Age at Attainment of Tanner 2 Breast Development	Early Untreated		12.14	Standard Error 0.31	years

1 to 10 of 182Source ClinicalTrials.gov

See all 182 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Early Treated	36
Overall Study	STARTED	Early Untreated	33
Overall Study	COMPLETED	Early Treated	22
Overall Study	COMPLETED	Early Untreated	20
Overall Study	NOT COMPLETED	Early Treated	14
Overall Study	NOT COMPLETED	Early Untreated	13

Source ClinicalTrials.gov

Adverse events210

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Palpitations	Cardiac disorders	Early Treated	2	36	2
other	Palpitations	Cardiac disorders	Early Untreated	0	33	0
other	Conductive deafness	Ear and labyrinth disorders	Early Treated	4	36	4
other	Conductive deafness	Ear and labyrinth disorders	Early Untreated	1	33	1
other	Ear pain	Ear and labyrinth disorders	Early Treated	6	36	8
other	Ear pain	Ear and labyrinth disorders	Early Untreated	3	33	4
other	Hearing impaired	Ear and labyrinth disorders	Early Treated	2	36	2
other	Hearing impaired	Ear and labyrinth disorders	Early Untreated	3	33	3
other	Tympanic membrane perforation	Ear and labyrinth disorders	Early Treated	7	36	8
other	Tympanic membrane perforation	Ear and labyrinth disorders	Early Untreated	2	33	2

1 to 10 of 210Source ClinicalTrials.gov

See all 210 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Early Treated
Total, all-cause mortality	Early Untreated
Total, other adverse events	Early Treated	34	36
Total, other adverse events	Early Untreated	32	33
Total, serious adverse events	Early Treated	6	36
Total, serious adverse events	Early Untreated	5	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Early Treated vs Early Untreated: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00266656

GET https://conductscience.org/api/trials/v1/NCT00266656/results?page=2

API reference For AI assistants