Nandrolone Decanoate as Anabolic Therapy in Chronic Kidney Disease: A Randomized Phase II Dose-Finding Study

Abstract

Background/Aims: In patients with chronic kidney disease (CKD) receiving adequate erythropoietin therapy, the ideal dose of nandrolone decanoate (ND) to enhance muscle mass is not known. Methods: In this phase II dose-finding study, 54 patients with CKD stage 5 were randomized to either low, medium or high doses of ND (50, 100 or 200 mg/week for 24 weeks, respectively, in males; doses halved in females), while 7 patients acted as non-randomized controls. The primary outcome measure was appendicular lean mass (ALM) by dual-energy X-ray absorptiometry. Fluid overload (hydration of the fat-free mass) and indicators of physical functioning were secondary measures. Harms were also recorded. Data were analysed using Quade’s (1967) non-parametric analysis of covariance. Results: ND increased ALM in a dose-responsive manner (change scores = 0.3 ± 0.3 vs. 0.8 ± 0.3 vs. 1.5 ± 0.5 vs. 2.1 ± 0.4 kg, control vs. low vs. medium vs. high dose groups, respectively, p < 0.001) with no increases in fluid overload but no consistent effect on physical functioning. The highest dose of ND (100 mg/week) was intolerable in females because of virilizing effects. Conclusion: If goals of future studies are to improve body composition, dosing of ND up to 200 mg/week in males and 50 mg/week in females should be investigated. However, to realize improvements in physical functioning, future phase III trials of ND may require additional interventions such as exercise training.

A Patient with CKD and Poor Nutritional Status

“…Several RCTs performed in maintenance HD patients showed significant benefits of nandrolone decanoate treatment in both anthropometric and biochemical measures, including body weight; body mass index; skinfold; mid-arm muscle circumference; and serum levels of total protein, prealbumin, and transferrin. No consistent effect of nandrolone decanoate was demonstrated on physical functioning in several studies, and high-dose nandrolone decanoate (100 mg/week) was intolerable in women because of its virilizing effects (64,65). Anabolic steroids can be used for preventing sarcopenia, albeit under close supervision with use limited to 6 months.…”

Resistance Training for Patients with Rheumatoid Arthritis: Effects on Disability, Rheumatoid Cachexia, and Osteoporosis; and Recommendations for Prescription

“…Several anabolic agents, such as recombinant human GH and anabolic steroids, have been proposed for increasing muscle mass in sarcopenic/cachectic states (e.g. Bross et al, 1999;Johansen et al, 1999Johansen et al, , 2006Macdonald et al, 2007). However, GH therapy is expensive and may cause carpal tunnel syndrome and insulin resistance, whilst anabolic steroids are associated with side effects such as liver disorders, masculinisation in women, and prostate cancer and testicular atrophy in men (Bhasin, 2003;Johansen et al, 1999;Korkia & Stimson, 1997;Macdonald et al, 2007).…”

“…Bross et al, 1999;Johansen et al, 1999Johansen et al, , 2006Macdonald et al, 2007). However, GH therapy is expensive and may cause carpal tunnel syndrome and insulin resistance, whilst anabolic steroids are associated with side effects such as liver disorders, masculinisation in women, and prostate cancer and testicular atrophy in men (Bhasin, 2003;Johansen et al, 1999;Korkia & Stimson, 1997;Macdonald et al, 2007). Furthermore, when used alone, despite increasing lean mass, these drugs often fail to improve physical function (Bross et al, 1999;Johansen et al, 2006;Macdonald et al, 2007;Rodriguez-Arnao et al, 1999).…”

“…However, GH therapy is expensive and may cause carpal tunnel syndrome and insulin resistance, whilst anabolic steroids are associated with side effects such as liver disorders, masculinisation in women, and prostate cancer and testicular atrophy in men (Bhasin, 2003;Johansen et al, 1999;Korkia & Stimson, 1997;Macdonald et al, 2007). Furthermore, when used alone, despite increasing lean mass, these drugs often fail to improve physical function (Bross et al, 1999;Johansen et al, 2006;Macdonald et al, 2007;Rodriguez-Arnao et al, 1999). Consistent with these findings, are the findings of an unpublished randomised controlled trial we conducted (Elamanchi et al, manuscript in preparation), in which nandrolone decanoate (ND), an anabolic steroid, was administered (i.m.…”

Matched‐cohort study of body composition, physical function, and quality of life in men with idiopathic vertebral fracture

“…The best of 3 maximal efforts was recorded. Adequate reliability of these physical function and strength tests has been shown previously by our group in patients with chronic kidney disease (24), and standard verbal instructions were provided by the unblinded assessors to motivate participants equally in each group.…”