EDC for growth hormone deficiency clinical trials
A growth trial is a measurement problem: precise heights, exact intervals, hormone levels and years of weekly injections. Capture stores each measurement with its date and audit trail. Build and test free, no credit card.
- Auxology by visit
- IGF-1 and bone age
- Caregiver injection diary
Free sandbox · No credit card · 21 CFR Part 11 compliant
| Assessment | Screen | Base | Wk 13 | Wk 26 | Wk 39 | Wk 52 |
|---|---|---|---|---|---|---|
| Standing height, weight, Tanner stage | ||||||
| IGF-1 and IGFBP-3 | ||||||
| Bone age X-ray | ||||||
| Glucose, HbA1c, thyroid | ||||||
| Anti-drug antibodies | ||||||
| Injection diary reviewed | D | D | D | D | D |
x = done at this visit, D = caregiver diary reviewed. Illustrative only.
What a growth hormone deficiency trial needs from its EDC
- A primary endpoint built from heights: pivotal paediatric trials of daily and long-acting growth hormone have used annualised height velocity (cm per year) at week 52, with height standard deviation score, IGF-1 SDS, IGFBP-3 and bone age as supporting measures.
- Measurement quality is data quality: a stadiometer reading taken on the wrong day or by a different technique can move velocity by more than the treatment effect. Method, device, measurer and repeat readings need fields.
- Children, caregivers and assent: participants are children, injections are given by a parent, and consent has to combine parental permission with age-appropriate assent.
- Long safety horizon: glucose metabolism, thyroid function, injection site reactions, scoliosis, hip pain and headache or visual change are followed over extension years, often until final height.
- An adult counterpart: adult GHD trials swap growth for body composition, lipids and quality of life, using the same forms in a different mix.
Auxology and hormones
Height velocity is a derived number: capture the two heights and the exact dates
In the registered 52-week phase 3 trial of lonapegsomatropin (heiGHt), the primary endpoint was annualised height velocity at week 52 in treatment-naive prepubertal children, compared with daily somatropin, with change in height SDS, IGF-1, IGF-1 SDS, IGFBP-3 and bone age as secondary measures. Registry entries for other weekly products list height velocity at 12 months first, with height SDS and IGF-1 SDS as outcomes. Which measure is primary depends on your protocol and regulator; the pattern for the data is the same. Velocity is not measured, it is calculated from two heights and the number of days between them, and the SDS depends on a chosen reference population, age and sex.
That drives the form design. Capture records height, weight and the measurement date at every visit, and can calculate age from date of birth, BMI, and minutes or hours between date-times. It does not include a height velocity or SDS calculator and does not store growth reference tables, so annualised velocity and SDS are derived in analysis from the exported dates and values with the reference your protocol names. This keeps one source of truth and avoids a calculation in the form that may later disagree with the statistical analysis plan. Record the stadiometer or device, the measurer, whether the child was barefoot, the time of day, and a second reading where the protocol requires repeat measurements. An edit check can raise a query when height falls between visits by more than a margin you set, or when the interval between two visits is outside a window; see visit window calculator.
Hormone and bone data sit beside the heights. IGF-1 is usually measured centrally and interpreted against age- and sex-specific ranges, and safety monitoring often keeps it within a protocol-defined band, so the lab result, unit and reference range belong on the lab results template, with lab data and reference range management for multi-lab studies. Bone age is read from a hand and wrist radiograph; Capture holds the reader, reading date and result, and does not store images. The thyroid panel template covers the TSH and free T4 safety checks that many protocols include. Diagnosis and eligibility often hinge on provocative GH stimulation results and growth criteria; peak thresholds vary by region and guideline, so enter the test, peak value and unit and let your protocol, not the form, define eligibility.
Adult growth hormone deficiency
Adult programmes have no growth endpoint. They typically follow changes in body composition (for example lean mass and fat mass by DXA), lipids, bone markers and disease-specific quality of life, together with IGF-1 and glucose safety. The DXA body composition template fits the body-composition part, and a disease-specific quality-of-life questionnaire is a licensed-instrument question handled in your study documents. Dose titration against IGF-1 in adults means a dose-change log with dates and reasons.
Measurement date
VSDTCStanding height, reading 1
HEIGHT1Standing height, reading 2
HEIGHT2Age at visit
AGECalculated from date of birth
6.8 years CalculatedWeight
WEIGHTHeight lower than last visit
HGTDROPEdit check found no decrease
Protocol to build
Growth hormone protocol elements and how they map to Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Diagnosis and eligibility | Stimulation test, peak value, auxology criteria, bone age | Screening form; eligibility screening template |
| Growth measurements | Heights with dates, device, measurer, repeat readings | Visit form with range and decrease checks; vital signs pattern |
| Pubertal status | Tanner stage, date | Visit form; skip logic for prepubertal-only criteria |
| IGF-1, IGFBP-3, glucose, thyroid | Value, unit, reference range, lab | Lab results template, thyroid panel |
| Dosing | Weekly or daily dose by weight, missed doses, site rotation | Repeating rows or caregiver diary |
| Immunogenicity | Anti-drug antibody result by visit | Lab form with central lab result |
| Safety | Injection-site reactions, headache, hip or knee pain, scoliosis, glucose | Adverse event form with injection-site fields |
| Quality of life (children) | Parent- and child-reported scales | PedsQL layout; licence in study documents |
Capture has no growth chart tables. Derive velocity and SDS in analysis against the reference your protocol names.
Build the auxology form and check the interval logic
Create the visit form with repeat heights, enter fake children at several visits, and test the decrease check. Free sandbox, no credit card.
Consent, caregivers and extensions
Assent, weekly injections at home and following children to final height
Paediatric consent needs two voices. Capture eConsent supports a parent or legally authorised representative signature alongside on-screen assent for the child, with email confirmation, countersignature by the investigator and exportable signed PDFs; the pediatric assent template is a starting point, and the age bands and wording are for your ethics committee to approve. For the clinical context of children in trials, see EDC for pediatric clinical trials.
Weekly injections happen at home, so adherence is a caregiver-reported record. A diary opened from a secure link in the phone browser, with reminders, can capture date and time of each injection, dose given, injection site and any reaction. This is a log, not proof of administration, and the protocol should say how missed doses are classified. See patient diary software and EDC with built-in ePRO. For caregivers who dislike installing apps, BYOD ePRO without an app download explains the browser approach.
Extension studies can follow children for years, until near-final height, through puberty and sometimes a switch of product. Treat each epoch as a block of visits with its own forms, keep the same participant ID, and plan how the pubertal onset and treatment changes will be recorded. Role-based access and PII segregation keep names with site coordinators and coded IDs with researchers. If you run several clinics, multi-site clinical trial management describes site numbering and by-site exports. For the wider hormone picture, see EDC for endocrinology trials, and for rare causes and syndromes, EDC for rare disease trials.
Before first participant
Growth hormone deficiency readiness checklist
Measurement method fixed
Device, technique, repeat readings and measurer role written in form help text.
Visit intervals defined
Window for each 13-week visit so annualisation intervals are known.
Reference for SDS named
Growth reference and version recorded in the statistical plan, not left to the programmer.
Lab ranges loaded
IGF-1 age- and sex-specific ranges agreed with the central lab.
Assent route tested
Parent signature plus child assent flow checked end to end.
Diary tested
Caregiver completes a mock injection log from a phone link.
Does Capture calculate height velocity or SDS?
No. Capture records heights, dates and calculates age from date of birth, BMI and similar listed fields. Annualised velocity and SDS are derived in analysis from the export using your protocol reference.
Can I flag an impossible height decrease?
Yes. An edit check with a rule you define raises an automatic query when a value falls below the previous one by more than a set margin. The reference interval comes from your protocol.
Can caregivers log injections on a phone?
Yes. A diary opens from a secure link in the phone browser with reminders. It records the caregiver report; it is not proof of administration.
Can I store bone age images?
No image storage is claimed. Record the reader, reading date and result from the radiograph report.
Does it work for adult GHD trials?
Yes. Use body composition, lipid, IGF-1 and quality-of-life forms and a dose-change log instead of the growth forms.
Can I get SDTM datasets?
Yes. Capture exports CDISC SDTM as SAS XPT files with Define-XML, alongside CSV and Excel with an automatic data dictionary.
How much does it cost?
The sandbox is free with nearly every feature, no credit card. Plans and prices are on the pricing page.
Keep exploring
Related pages
EDC for endocrinology trials
Hormone and metabolic overview.
EDC for pediatric clinical trials
Children, assent and caregivers.
EDC for rare disease trials
Small populations.
Pediatric assent template
Parent permission plus child assent.
Lab results template
Analyte, unit, result, range.
Patient diary software
Caregiver injection logs.
Pricing
Free sandbox.
Start your growth study free
Free sandbox with nearly every feature. No credit card.