Trial · NCT00191113
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population | Baseline, and end of 4-year addendum | 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. |
| Primary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height | at completion of core study, or at end of 4-year addendum | 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. |
| Secondary | Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population | every 3 months during core study, and at start and end of 4-year addendum | 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. |
| Secondary | Height (Centimeters [cm]) | every 3 months during core study, and at start and end of 4-year addendum | Most mature measurement available, at or after attainment of Final Height. |
| Secondary | Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum | |
| Secondary | Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment | at completion of core study or beginning of addendum | |
| Secondary | Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment | at completion of core study or beginning of addendum | |
| Secondary | Number of Participants With Hearing Loss, Audiologist Assessment | at completion of core study or beginning of addendum | 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. |
| Secondary | Fasting Glucose, Change From Baseline | At core study baseline, and at end of 4-year addendum | Change from core study baseline to addendum 2 maximum. |
| Secondary | Maximum Fasting Glucose Value | At start and through end of 4-year addendum (up to an additional 2 years) | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. |
| Secondary | Number of Participants With Any Abnormal Fasting Glucose Value | At start and through end of 4-year addendum | 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). |
| Secondary | Maximum Fasting Insulin Values | At start and through end of 4-year addendum (up to an additional 2 years) | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. |
| Secondary | Number of Participants With Any Abnormal Fasting Insulin Value | At start and through end of 4-year addendum | 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). |
| Secondary | Minimum Fasting Glucose/Insulin Ratio Values | At start and through end of 4-year addendum (up to an additional 2 years) | Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years. |
| Secondary | Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value | At start and through end of 4-year addendum | 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). |
| Secondary | Glycosylated Hemoglobin, Change From Baseline | At core study baseline, and at end of 4-year addendum | Change from core study baseline to addendum 2 maximum. |
| Secondary | Maximum Glycosylated Hemoglobin | At start and through end of 4-year addendum (up to an additional 2 years) | Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. |
| Secondary | Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value | At start and through end of 4-year addendum | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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