severe Adult Growth Hormone Deficiency, vitamin D deficiency or insufficiency
Conditions
Interventions
1. Weekly GH (somatropin) and vitamin D preparation (alfacalcidol) combination therapy (GH+D group).
Somatropin: Start with 1.5 mg per week (2.0 mg per week for women taking oral estrogen
1.0 mg per week is also acceptable for patients aged 60 years or older). Adjust the dosage so that IGF-I SDS remains between -2 and +2.
2.Weekly GH (somatropin) monotherapy (GH group).
Somatropin dose
Sponsors
Fukuoka Hidenori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older. 2. Patients diagnosed with severe adult growth hormone deficiency (AGHD) based on the Guidelines for Diagnosis and Treatment of Adult Growth Hormone Deficiency . 3. Patients with vitamin D insufficiency or deficiency (25(OH)vitamin D <30ng/ml). 4. Patients with no history of GHRT treatment within the past year. 5. Patients for whom written informed consent to participate in this study has been obtained.
Exclusion criteria
Exclusion criteria: 1. Patients with severe renal impairment (eGFR 0.3, serum corrected Ca > 10.2 mg/dl, or serum corrected Ca < 8.4 mg/dl 6. Patients meeting the diagnostic criteria for osteomalacia (Appendix 2) 7. Patients with a bone mineral density (BMD) T-score less than -3.3 SD 8. Patients with a history of fragility fractures 9. Patients with malignant tumours. 10. Patients deemed unsuitable by the principal investigator of this clinical study. 11. Patients with allergies to somapisitan or alfacalcidol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline to 104 weeks after initiation of protocol treatment in the following indicators Bone density: Bone mineral density measured by DEXA (Lumber 2-4) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Efficacy evaluation items) Changes in the following indicators between baseline and 104 weeks after the start of protocol treatment 1. Bone metabolism markers (TRACP-5b, BAP), bone mineral density and YAM values measured by DEXA (femoral neck, femoral total, radius one third), and trabecular bone score (TBS) measured by DEXA 2. Muscle mass: Lean body mass measured by DEXA method 3. Muscle strength: Muscle strength measured by a grip strength meter 4. Body fat percentage: percent Fat and waist circumference measured by DEXA method 5. Glucose metabolism: Fasting plasma glucose (FPG), fasting insulin (F-IRI), and HbA1c 6. Lipid metabolism: Lipid profile (T-chol, HDL-chol, LDL-chol, TG) 7. Fatty liver: Fib4 index 8. Adherence: Determined based on changes in serum IGF-I levels [If IGF-I levels do not increase compared to before GH therapy initiation (IGF-I levels are determined based on Endocrine J. 2012: 59(9): 771-80 as a reference), or if they decrease despite an increase in GH agent dosage, or if the medication adherence checkbox is marked on the symptom checklist, adherence is deemed poor.] (Safety evaluation items) Occurrence of diseases or conditions during the treatment period (Definition: Occurrence of diseases or conditions related to protocol treatment. Where the same disease or condition is observed multiple times in the same subject, the most severe grade is used.) | — |
Contacts
Public ContactSeiji Tomofuji
Kobe University Graduate School of Medicine
Outcome results
None listed