Table 1.
Visit schedule and assessments.
| Parameter (if appropriate / performed) | Visit 1 (baseline / start) | Subsequent visits (intervals corresponding to routine clinical practice) |
|---|---|---|
| Informed consent | x | |
| Date of visit | x | x |
| Patient data (sex, DOB) | x | DOB for identification purposes |
| Diagnosis (date, aetiology) | x | |
| Additional hormone deficiencies | x | |
| Anamnesis and medical history | x | |
| Family history | x | |
| Puberty (date of onset, menarche) | x | |
| Smoking habits | x | x |
| Radiotherapy | x | |
| Glucose homeostasis | x | x |
| Scoliosis | x | x |
| Osteoporosis | x | x |
| Cardiovascular examination | x | x |
| Previous, current and chronic relevant illnesses | x | |
| Current drug treatment / concomitant medication | x | x |
| Previous GH treatment | x | |
| Height | x | |
| Weight | x | x |
| Waist and hip circumference | x | x |
| Physical examination | x | x |
| Vital signs | x | x |
| Body composition | x | x |
| Bone densitometry | x | x |
| Ophthalmologic examinations | x | x |
| Electrocardiogram | x | x |
| CT, MRI and sonography results | x | x |
| Haematology | x | x |
| Blood chemistry | x | x |
| Glucose metabolism / OGTT | x | x |
| HOMA | x | x |
| Fasting lipid profile | x | x |
| Urinalysis | x | x |
| Hormones (thyroid, gonadal, adrenal function) | x | x |
| IGF-1, IGFBP-3 determinations | x | x |
| Anti-hGH antibody determination | x | x |
| GH stimulation test(s) | x | |
| Spontaneous GH secretion | x | |
| Omnitrope® dose | x | x |
| Adverse events | x | |
| Discontinuation (reasons) | x | |
| QoL assessment* | x | x |
*
In certain countries. CT, computerized tomography; DOB, date of birth; GH, growth hormone; hGH, human growth hormone; HOMA, homeostatic model assessment; IGF, insulin-like growth factor; IGFBP, insulin-like growth factor binding protein; MRI, magnetic resonance imaging; OGTT, oral glucose tolerance test; QoL, quality of life.