Zoetermeer Study: double-blind randomised, placebo-controlled clinical study to investigate the effects of daily oral atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day) alone and in a combined regimen on physical frailty and quality of life in 100 elderly male volunteers over a treatment period of 36 weeks

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: 1. Atamestane (100 mg/day) 2. Dehydroepiandrosterone (50 mg/day) 3. Combined regimen of atamestane (100 mg/day) and dehydroepiandrosterone (50 mg/day) CONDITION: Physical frailty ; Not Applicable PRIMARY OUTCOME: 1. Isometric grip strength; 2. Leg extension power; 3. Physical performance (according to Guralnik) SECONDARY OUTCOME: 1. Activities of Daily Living; 2. Quality of life; 3. Mini Mental State Examination; 4. Body composition; 5. Bone density of hip; 6. Bone metabolism; 7. Hormonal parameters total testosterone, dehydroepiandrosterone (DHEA), dehydroepiandrosterone sulphate (DHEAS), oestradiol, oestrone, sex hormone binding globulin (SHBG), insulin‐like growth factor 1 (IGF‐1), IGF‐binding proteins (IGFBP), IGF‐binding protein 3 (IGFBP3); 8. Glucose, insulin HbA1c; 9. Immunological parameters (lymphocyte sub‐populations and surface markers); 10. Lipid metabolism (high density lipoproetin [HDL], low density lipoprotein [LDL], triglycerides, cholesterol); 11. Carotid intima‐media thickness INCLUSION CRITERIA: 1. Men 2. 70 years or older 3. Participant in previous cross‐sectional study among 400 men 4. Low performance score on isometric grip strength (IGS) and leg extensor power (LEP) test compared to mean of 400 men in cross‐sectional study
Epistemonikos ID: 7abc612d7139f46485f0a399bd76fc3b5b6b33ae
First added on: Aug 21, 2024