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The Impact of Vitamin D Sufficiency on Bone and Skeletal Muscle During Growth Hormone Replacement Therapy

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	severe Adult Growth Hormone Deficiency, vitamin D deficiency or insufficiency
Date of first enrollment	08/12/2025
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	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 adjustment should be performed in the same manner as in the GH+D group. 3.Vitamin D preparation (alfacalcidol) monotherapy (D group). Alfacalcidol: 0.75 micrograms per day, administered orally once daily. All groups (1, 2, and 3) will be evaluated at baseline and at 104 weeks after the start of protocol treatment. Note: Dose adjustment of somatropin is limited to the first 26 weeks, after which it will be fixed. 3) Only patients who did not consent to GHRT but did consent to oral vitamin D supplementation and study participation will be enrolled. Furthermore, to ensure consistent timing of IGF-I measurement across the GH+D and GH groups, blood tests will be conducted on day 4 following weekly GH (somatropin) administration.

Outcome(s)

Primary Outcome

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 Outcome

(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.)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude criteria	1. Patients with severe renal impairment (eGFR < 30) 2. Patients who are pregnant or breastfeeding 3. Patients currently using osteoporosis treatments (excluding vitamin K and oestrogen replacement therapy), calcium preparations, or calcium-containing supplements 4. Patients who have used vitamin D preparations or vitamin D-containing supplements within the past year. 5. Patients meeting any of the following criteria: urinary Ca/Cr > 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 or equal to -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