Durability of the Effects of Testosterone and Growth Hormone Supplementation in Older Community Dwelling Men: The HORMA Trial.

Abstract

Objectives-Determine the durability of anabolic effects and adverse events (AEs) after stopping testosterone and growth hormone supplementation in older men.Design-Secondary analysis of a double-masked, randomized controlled trial of testosterone gel (5g or 10g/daily) plus rhGH (0, 3, or 5ug/kg/day) with follow-up of outcomes 3-months later.Participants-108 community-dwelling 65-90 year-old-men.Measurements-Testosterone and IGF-1 levels, body composition (DEXA), 1-repetition maximum (1-RM) strength, stair-climbing power, quality-of-life (QOL) and activity questionnaires, AEs.Results-Despite improvements in body composition during treatment, residual benefits 3-months later (week-28) were variable. For participants with improvements exceeding their week-17 median changes, benefits were sustained at week 28 for lean body mass (LBM, 1.45±1.63kg, 45% of week-17 values, p<0.0001-vs-baseline), appendicular skeletal muscle mass (ASMM, 0.71±1.01kg, 42%, p<0.0001), total fat (-1.06±2.18kg, 40%, p<0.0001,), and trunk fat (-0.89±1.42kg, 50%, p<0.0001,); retention of ASMM was associated with greater week-16 protein intake (p=0.01). For 1-RM strength, 39%-43% of week-17 improvements (p≤0.05) were retained and associated with better week-17 strength (p<0.0001), change in testosterone from week-17-to-28 (p=0.004) and baseline PASE (p=0.04). Framingham 10-year cardiovascular risks were low Conclusions-Durable improvements in muscle mass, strength, and fat mass were retained 3-months after discontinuing hormone supplementation in participants with greater than median body composition changes during treatment, but not in others with smaller gains. AEs largely resolved after intervention discontinuation. Additional strategies may be needed to sustain or augment muscle mass and strength gains achieved during short-term hormone therapy.

Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial

“…8,38 The upper age limit was established to increase the probability that the study participants would be eugonadal. 11,22,36,42,43 Inclusion criteria were (1) a history of trauma to a previously uninjured knee within the preceding 8 months, (2) ACL insufficiency as determined by a clinical examination, and (3) a score of 5 to 9 on the Tegner activity scale (TAS) before the injury, with a score of 5 indicating participation in recreational sports and a score of 9 indicating participation in competitive sports at a nonprofessional level. Major exclusion criteria included previous surgery to the affected knee or concomitant injuries to the posterior cruciate ligament and collateral ligaments.…”

“…2 Furthermore, studies have demonstrated that testosterone supplementation sufficient to increase muscle mass is possible without adverse effects on lipids, mood, or behavior. 4,7,42…”

Androgen effects on skeletal muscle: implications for the development and management of frailty

“… 111 113 117 Studies in healthy and frail older men suggest most of this benefit is lost within 3–6 months of discontinuing treatment, although in men experiencing the largest gains some residual benefits may remain at 3 months. 139 140 …”