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CompletedNCT00191113GDCTUpdated Jan 27, 2010Results posted

Somatropin Treatment to Final Height in Turner Syndrome

A Phase 3 interventional study of Somatropin and Ethinyl estradiol in Turner Syndrome, sponsored by Eli Lilly and Company. Completed at 14 sites in Canada. Open to female participants aged 7 Years to 13 Years. Per ClinicalTrials.gov, last updated 2010-01-27.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
7 Years to 13 Years
Sex
Female
01

Study summary

A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

Read the detailed description

A randomized, controlled trial of Humatrope (somatropin) treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry.

Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome, and to assess the safety of this treatment. Core study completion criteria (protocol final height) are that the patient has both a height velocity \< 2 cm per year and a bone age of 14 years or greater.

Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19, 1997.

Addendum 2 objectives are: 1) to collect true final height data; 2) to evaluate hearing, tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome; 3) to evaluate pancreatic beta cell function (glucose metabolism) in patients previously enrolled in the Core study.

Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study, and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy.

02

Conditions studied

  • Turner Syndrome

Keywords

  • syndrome
  • Turner
  • Turner's
  • height
  • growth
  • growth hormone
  • somatropin
  • short stature
  • short
  • hearing
  • glucose metabolism
03

In context

Turner Syndrome

115 studies on the registry are indexed under Turner Syndrome; 33 are open to participants now.

This study's enrollment of 154 is above the median of 65 across 51 interventional studies indexed under Turner Syndrome.

Browse Turner Syndrome studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 13 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • girl with Turner syndrome
  • prepubertal, Tanner stage I breast
  • height velocity less than 6 cm/year and height less than or equal to the tenth percentile for sex and age in general population
  • at least 6 months (preferably 12 months) of accurate height measurements available for calculation of pre-study height velocity
  • if thyroxine deficient, to have received replacement therapy, and for six months prior to enrollment have had normal thyroid function tests

Exclusion criteria

Exclusion Criteria:

  • prior treatment with growth hormone
  • presence of a Y component in karyotype with gonads in situ
  • diabetes mellitus
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • No intervention
    Control

    Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).

    Drug: Ethinyl estradiol · Drug: Medroxyprogesterone acetate

  • Experimental
    Humatrope

    Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).

    Drug: Somatropin · Drug: Ethinyl estradiol · Drug: Medroxyprogesterone acetate

Interventions

  • DrugSomatropin

    0.05 mg/kg/dose by subcutaneous injection 6 times per week, until Core study completion criteria are met (protocol final height).

    Also known as: Humatrope, Growth hormone

  • DrugEthinyl estradiol

    escalating doses 2.5-20.0 mcg tablets daily after age 13 and at least one year on study, continuing until Core study completion criteria are met.

  • DrugMedroxyprogesterone acetate

    10 mg tablets, ten days monthly, after age 15, continuing until Core study completion criteria are met.

06

What researchers measure

Primary outcomes

  1. Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population

    Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.

    Time frame: Baseline, and end of 4-year addendum

  2. Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height

    SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS \[NCHS\] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS \[Lyon\] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS \[NCHS\] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.

    Time frame: at completion of core study, or at end of 4-year addendum

Secondary outcomes

  1. Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population

    Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.

    Time frame: every 3 months during core study, and at start and end of 4-year addendum

  2. Height (Centimeters [cm])

    Most mature measurement available, at or after attainment of Final Height.

    Time frame: every 3 months during core study, and at start and end of 4-year addendum

  3. Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment

    Time frame: at completion of core study or beginning of addendum

  4. Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment

    Time frame: at completion of core study or beginning of addendum

  5. Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment

    Time frame: at completion of core study or beginning of addendum

  6. Number of Participants With Hearing Loss, Audiologist Assessment

    Sensorineural Hearing Loss (SNHL)=air conduction threshold \>20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold \>20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap \>10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.

    Time frame: at completion of core study or beginning of addendum

  7. Fasting Glucose, Change From Baseline

    Change from core study baseline to addendum 2 maximum.

    Time frame: At core study baseline, and at end of 4-year addendum

  8. Maximum Fasting Glucose Value

    Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

    Time frame: At start and through end of 4-year addendum (up to an additional 2 years)

  9. Number of Participants With Any Abnormal Fasting Glucose Value

    Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose \>=100 milligrams per deciliter (mg/dL).

    Time frame: At start and through end of 4-year addendum

  10. Maximum Fasting Insulin Values

    Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

    Time frame: At start and through end of 4-year addendum (up to an additional 2 years)

  11. Number of Participants With Any Abnormal Fasting Insulin Value

    Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin \>=35 micro International Units per milliliter (uIU/mL).

    Time frame: At start and through end of 4-year addendum

  12. Minimum Fasting Glucose/Insulin Ratio Values

    Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.

    Time frame: At start and through end of 4-year addendum (up to an additional 2 years)

  13. Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value

    Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio \<=4.5 milligrams per 10\^-4 Units (mg/10\^-4U).

    Time frame: At start and through end of 4-year addendum

  14. Glycosylated Hemoglobin, Change From Baseline

    Change from core study baseline to addendum 2 maximum.

    Time frame: At core study baseline, and at end of 4-year addendum

  15. Maximum Glycosylated Hemoglobin

    Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

    Time frame: At start and through end of 4-year addendum (up to an additional 2 years)

  16. Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value

    Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).

    Time frame: At start and through end of 4-year addendum

07

Results

Posted Jan 27, 2010

Participant flow

Addenda 1, 2, and 3 are not sequential, and they differ in eligibility criteria. Depending on individual eligibility and choices made, a patient might have participated in none, 1, 2, or all 3 of these addenda.

Core Study
Participant flow — Core Study
MilestoneAs-Randomized ControlAs-Randomized Humatrope
Started7876
Completed4361
Not completed3515
Withdrew: Withdrawal by subject259
Withdrew: Protocol violation62
Withdrew: Lost to follow-up30
Withdrew: Adverse event02
Withdrew: Lack of efficacy02
Withdrew: Death10
Addendum 1
Participant flow — Addendum 1
MilestoneAs-Randomized ControlAs-Randomized Humatrope
Started20
Completed20
Not completed00
Addendum 2
Participant flow — Addendum 2
MilestoneAs-Randomized ControlAs-Randomized Humatrope
Started2848
Completed1831
Not completed1017
Addendum 3
Participant flow — Addendum 3
MilestoneAs-Randomized ControlAs-Randomized Humatrope
Started2037
Completed2037
Not completed00

Outcome measures

PrimaryHeight Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population

Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.

Time frame:
Baseline, and end of 4-year addendum
Reported as:
Least squares mean · Standard Deviation Score (SDS) [NCHS]
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population
Standard Deviation Score (SDS) [NCHS]As-Randomized ControlAs-Randomized Humatrope
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population0.09 ± 0.070.97 ± 0.07
Statistical analysis
  • As-Randomized Control vs As-Randomized Humatrope · ANCOVA · p = <0.001 · Mean difference (final values): 0.9 · 95% CI 0.7 to 1.1Effect direction is "As-Randomized Humatrope" minus "As-Randomized Control"
PrimaryHeight Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height

SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS \[NCHS\] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS \[Lyon\] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS \[NCHS\] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS.

Time frame:
at completion of core study, or at end of 4-year addendum
Reported as:
Least squares mean · Standard Deviation Score (SDS) [NCHS]
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height
Standard Deviation Score (SDS) [NCHS]As-Treated No Growth HormoneAs-Treated Growth Hormone
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height-3.30 ± 0.07-2.25 ± 0.05
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · ANCOVA · p = <0.001 · Mean difference (final values): 1.0 · 95% CI 0.9 to 1.2Effect direction is "As-Treated Growth Hormone" minus "As-Treated No Growth Hormone"
SecondaryHeight Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population

Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height.

Time frame:
every 3 months during core study, and at start and end of 4-year addendum
Reported as:
Least squares mean · Standard Deviation Score (SDS) [NCHS]
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population
Standard Deviation Score (SDS) [NCHS]As-Treated No Growth HormoneAs-Treated Growth Humatrope
Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population-0.09 ± 0.080.99 ± 0.06
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Humatrope · ANCOVA · p = <0.001 · Mean difference (net): 1.1 · 95% CI 0.9 to 1.3
SecondaryHeight (Centimeters [cm])

Most mature measurement available, at or after attainment of Final Height.

Time frame:
every 3 months during core study, and at start and end of 4-year addendum
Reported as:
Least squares mean · centimeters (cm)
Height (Centimeters [cm])
centimeters (cm)As-Treated No Growth HormoneAs-Treated Growth Humatrope
Height (Centimeters [cm])141.63 ± 0.47148.52 ± 0.36
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Humatrope · ANCOVA · p = <0.001 · Mean difference (net): 6.9 · 95% CI 5.7 to 8.1
SecondaryNumber of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment
Time frame:
at completion of core study or beginning of addendum
Reported as:
Number · participants
Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment
participantsAs-Treated No Growth HormoneAs-Treated Growth Hormone
Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment1029
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · Fisher Exact · p = >0.999
SecondaryNumber of Participants With Abnormal Speech Audiometry, Audiologist Assessment
Time frame:
at completion of core study or beginning of addendum
Reported as:
Number · participants
Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment
participantsAs-Treated No Growth HormoneAs-Treated Growth Hormone
Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment312
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · Fisher Exact · p = 0.744
SecondaryNumber of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment
Time frame:
at completion of core study or beginning of addendum
Reported as:
Number · participants
Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment
participantsAs-Treated No Growth HormoneAs-Treated Growth Hormone
Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment218
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · Fisher Exact · p = 0.073
SecondaryNumber of Participants With Hearing Loss, Audiologist Assessment

Sensorineural Hearing Loss (SNHL)=air conduction threshold \>20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold \>20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap \>10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present.

Time frame:
at completion of core study or beginning of addendum
Reported as:
Number · participants
Number of Participants With Hearing Loss, Audiologist Assessment
participantsAs-Treated No Growth HormoneAs-Treated Growth Hormone
Conductive Hearing Loss17
Sensorineural Hearing Loss815
Mixed Hearing Loss29
Unspecified Hearing Loss11
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · Fisher Exact · p = >0.999
SecondaryFasting Glucose, Change From Baseline

Change from core study baseline to addendum 2 maximum.

Time frame:
At core study baseline, and at end of 4-year addendum
Reported as:
Least squares mean · mg / dL
Fasting Glucose, Change From Baseline
mg / dLTreated-As-Randomized ControlTreated-As-Randomized Humatrope
Fasting Glucose, Change From Baseline5.495 ± 2.4553.003 ± 1.830
Statistical analysis
  • Treated-As-Randomized Control vs Treated-As-Randomized Humatrope · ANOVA · p = 0.419 · Mean difference (final values): -2.492 · 95% CI -8.631 to 3.646Direction of estimated treatment effect is Humatrope minus Control
SecondaryMaximum Fasting Glucose Value

Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

Time frame:
At start and through end of 4-year addendum (up to an additional 2 years)
Reported as:
Mean · milligrams per deciliter (mg/dL)
Maximum Fasting Glucose Value
milligrams per deciliter (mg/dL)As-Treated No Growth HormoneAs-Treated Growth Hormone
Maximum Fasting Glucose Value85.2 ± 6.685.2 ± 10.4
SecondaryNumber of Participants With Any Abnormal Fasting Glucose Value

Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose \>=100 milligrams per deciliter (mg/dL).

Time frame:
At start and through end of 4-year addendum
Reported as:
Number · participants
Number of Participants With Any Abnormal Fasting Glucose Value
participantsAs-Treated No Growth HormoneAs-Treated Growth Humatrope
Number of Participants With Any Abnormal Fasting Glucose Value03
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Humatrope · Fisher Exact · p = 0.545
SecondaryMaximum Fasting Insulin Values

Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

Time frame:
At start and through end of 4-year addendum (up to an additional 2 years)
Reported as:
Mean · micro International Units per milliliter
Maximum Fasting Insulin Values
micro International Units per milliliterAs-Treated No Growth HormoneAs-Treated Growth Hormone
Maximum Fasting Insulin Values9.5 ± 10.89.7 ± 9.3
SecondaryNumber of Participants With Any Abnormal Fasting Insulin Value

Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin \>=35 micro International Units per milliliter (uIU/mL).

Time frame:
At start and through end of 4-year addendum
Reported as:
Number · participants
Number of Participants With Any Abnormal Fasting Insulin Value
participantsAs-Treated No Growth HormoneAs-Treated Growth Humatrope
Number of Participants With Any Abnormal Fasting Insulin Value12
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Humatrope · Fisher Exact · p = >0.999
SecondaryMinimum Fasting Glucose/Insulin Ratio Values

Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years.

Time frame:
At start and through end of 4-year addendum (up to an additional 2 years)
Reported as:
Mean · milligrams per 10^-4 Units (mg/[10^-4]U)
Minimum Fasting Glucose/Insulin Ratio Values
milligrams per 10^-4 Units (mg/[10^-4]U)As-Treated No Growth HormoneAs-Treated Growth Hormone
Minimum Fasting Glucose/Insulin Ratio Values12.5 ± 6.012.2 ± 5.3
SecondaryNumber of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value

Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio \<=4.5 milligrams per 10\^-4 Units (mg/10\^-4U).

Time frame:
At start and through end of 4-year addendum
Reported as:
Number · participants
Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value
participantsAs-Treated No Growth HormoneAs-Treated Growth Hormone
Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value13
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · Fisher Exact · p = >0.999
SecondaryGlycosylated Hemoglobin, Change From Baseline

Change from core study baseline to addendum 2 maximum.

Time frame:
At core study baseline, and at end of 4-year addendum
Reported as:
Least squares mean · percent (%)
Glycosylated Hemoglobin, Change From Baseline
percent (%)Treated-As-Randomized ControlTreated-As-Randomized Humatrope
Glycosylated Hemoglobin, Change From Baseline0.215 ± 0.0770.208 ± 0.057
Statistical analysis
  • Treated-As-Randomized Control vs Treated-As-Randomized Humatrope · ANOVA · p = 0.945 · Mean difference (final values): -0.007 · 95% CI -0.199 to 0.186Direction of estimated treatment effect is Humatrope minus Control
SecondaryMaximum Glycosylated Hemoglobin

Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years.

Time frame:
At start and through end of 4-year addendum (up to an additional 2 years)
Reported as:
Mean · percent (%)
Maximum Glycosylated Hemoglobin
percent (%)As-Treated No Growth HormoneAs-Treated Growth Hormone
Maximum Glycosylated Hemoglobin5.0 ± 0.55.0 ± 0.4
SecondaryNumber of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value

Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards).

Time frame:
At start and through end of 4-year addendum
Reported as:
Number · participants
Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value
participantsAs-Treated No Growth HormoneAs-Treated Growth Hormone
Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value00
Statistical analysis
  • As-Treated No Growth Hormone vs As-Treated Growth Hormone · Fisher Exact

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treated-As-Randomized Control—10/54 (18.5%)53/54 (98.1%)
Treated-As-Randomized Humatrope—22/74 (29.7%)74/74 (100%)
Most frequent serious events
Showing 10 of 37
Most frequent serious events
EventTreated-As-Randomized ControlTreated-As-Randomized Humatrope
TympanoplastySurgical and medical procedures0/543/74
AppendectomySurgical and medical procedures2/540/74
Arm fractureInjury, poisoning and procedural complications0/542/74
Idiopathic thrombocytopenic purpuraBlood and lymphatic system disorders1/540/74
Cardiac arrestCardiac disorders1/540/74
PneumoniaInfections and infestations1/540/74
Chest wall repairSurgical and medical procedures1/540/74
Pterygium operationSurgical and medical procedures1/541/74
Scar removalSurgical and medical procedures1/540/74
Surgical procedureSurgical and medical procedures1/540/74
Most frequent other events
Showing 10 of 94
Most frequent other events
EventTreated-As-Randomized ControlTreated-As-Randomized Humatrope
ColdInfections and infestations39/5442/74
HeadacheNervous system disorders25/5446/74
Sore throatRespiratory, thoracic and mediastinal disorders28/5437/74
FeverGeneral disorders20/5436/74
FluInfections and infestations20/5436/74
Otitis mediaInfections and infestations13/5431/74
VomitingGastrointestinal disorders21/5429/74
Ear infectionInfections and infestations12/5427/74
CoughRespiratory, thoracic and mediastinal disorders14/5427/74
Upper respiratory infectionInfections and infestations14/5413/74

Baseline characteristics

Age Continuous
Age Continuous(years)As-Randomized ControlAs-Randomized HumatropeTotal
Mean10.46 ± 1.7710.36 ± 1.8010.41 ± 1.78
Sex: Female, Male
Sex: Female, Male(Participants)As-Randomized ControlAs-Randomized HumatropeTotal
Female7876154
Male000
Region of Enrollment
Region of Enrollment(participants)As-Randomized ControlAs-Randomized HumatropeTotal
Canada7876154
Karyotype
Karyotype(participants)As-Randomized ControlAs-Randomized HumatropeTotal
45,X484593
45,X/46,XXqi628
45,X/46,XXr123
45,X/46,XX336
46,XXqi268
45,X/47,XXX123
46,XXp101
45,X/46,XXp112
45,X/46,XX/47,XXX000
46,XXr000
Other151530
Race/Ethnicity
Race/Ethnicity(participants)As-Randomized ControlAs-Randomized HumatropeTotal
American Indian or Alaska Native112
Asian7613
Native Hawaiian or Other Pacific Islander000
Black or African American101
White5466120
Hispanic022
Other404
Unknown11112
Bone Age
Bone Age(years)As-Randomized ControlAs-Randomized HumatropeTotal
Mean8.57 ± 1.518.79 ± 1.428.69 ± 1.46
Height
Height(centimeters)As-Randomized ControlAs-Randomized HumatropeTotal
Mean120.06 ± 8.26119.84 ± 8.45119.96 ± 8.33
Height Standard Deviation Score (SDS) [Lyon]
Height Standard Deviation Score (SDS) [Lyon](Standard Deviation Score (SDS))As-Randomized ControlAs-Randomized HumatropeTotal
Mean-0.13 ± 0.86-0.10 ± 0.88-0.11 ± 0.87

1 further baseline measures are reported on the registry.

08

Study locations

14 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Calgary, Alberta T2T 5C7, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Edmonton, Alberta T6G 2B7, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Vancouver, British Columbia V6H 3V4, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Winnipeg, Manitoba R3E 0Z2, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Halifax, Nova Scotia B3J 3G9, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Hamilton, Ontario L8S 3Z5, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Kingston, Ontario K7L 3N6, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    London, Ontario K7L 3N6, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Ottawa, Ontario K1H 8L1, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Toronto, Ontario M5G 1X8, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Montreal, Quebec H3H 1P3, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Montreal, Quebec H3T 1C5, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Sainte-Foy, Quebec G1V 4G2, Canada
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Sherbrooke, Quebec J1G 2E8, Canada
09

References and documents

Publications

  • Lyon AJ, Preece MA, Grant DB. Growth curve for girls with Turner syndrome. Arch Dis Child. 1985 Oct;60(10):932-5. doi: 10.1136/adc.60.10.932. PubMed 4062345 ↗
  • Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27. PubMed 11183293 ↗
  • Hamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. doi: 10.1210/jc.2006-0490. Epub 2006 Jun 6. PubMed 16757526 ↗
  • Stephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. doi: 10.1210/jc.2004-2187. Epub 2005 Mar 22. PubMed 15784709 ↗
  • Taback SP, Van Vliet G. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone. BMC Pediatr. 2011 May 29;11:49. doi: 10.1186/1471-2431-11-49. PubMed 21619701 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00191113
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Feb 1989
Primary completion
Dec 2007
Completion
Dec 2007
Results posted
Jan 27, 2010
Last update
Jan 27, 2010

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern Time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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