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PubMed1997

Oxandrolone, an anabolic steroid, significantly increases the rate of weight gain in the recovery phase after major burns.

We studied the effect of an anabolic steroid, oxandrolone, combined with a high-protein diet (2 g/kg/day) on the rate of weight gain and restoration of muscle function in the recovery phase after deep burns of 30 of 50% of total body surface (n = 7). The findings were compared with findings from an isocaloric (2 g/kg/day protein) diet alone (n = 6). The study was prospective and randomized. Data were also compared retrospectively with data from a group of burn patients treated in the same fashion using a high-calorie, high-protein diet with a protein content of 1.3 to 1.4 g/kg/day (n = 10). Muscle function was quantified using a physical therapy index defining rate of progress (0 = lowest, 10 = highest). Oxandrolone was given in the beginning of the recovery phase in a dosage of 10 mg orally twice a day. The recovery phase was defined as resolution of the hypermetabolic state using physiologic criteria. The study was performed in an acute burn rehabilitation facility where patients were transferred once entering the recovery phase. Patients in each group were not different with regard to age and burn size. We found that mean weight loss for all patients was 11 +/- 2% of preburn weight during the catabolic phase despite optimum nutrition and early wound closure. Data are presented as mean +/- SD. We found that the average weight gain during the first 3 weeks was 14.5 +/- 2.5 pounds and that the physical therapy index was 8.8 +/- 0.5 of recovery in the oxandrolone-protein group (n = 7); both of these values were significantly greater than the corresponding values in the other groups. In the high-protein alone group (n = 6), weight gain was 7.5 +/- 1.7 pounds and physical therapy index was 7.0 +/- 0.8. In the retrospective group (n = 10), weight gain was 4.4 +/- 0.8 pounds and function index was 4.1 +/- 0.5. The daily caloric intake was not different between groups. Protein content and oxandrolone were the variables. No side effects were noted with oxandrolone. We can conclude that an anabolic steroid combined with increased protein intake can significantly increase the rate of restoration of weight gain postburn.

Adult↗

PubMedDate not supplied

Effects of oxandrolone on outcome measures in the severely burned: a multicenter prospective randomized double-blind trial.

Severe burns induce pathophysiologic problems, among them catabolism of lean mass, leading to protracted hospitalization and prolonged recovery. Oxandrolone is an anabolic agent shown to decrease lean mass catabolism and improve wound healing in the severely burned patients. We enrolled 81 adult subjects with burns 20% to 60% TBSA in a multicenter trial testing the effects of oxandrolone on length of hospital stay. Subjects were randomized between oxandrolone 10 mg every 12 hours or placebo. The study was stopped halfway through projected enrollment because of a significant difference between groups found on planned interim analysis. We found that length of stay was shorter in the oxandrolone group (31.6 +/- 3.1 days) than placebo (43.3 +/- 5.3 days; P < .05). This difference strengthened when deaths were excluded and hospital stay was indexed to burn size (1.24 +/- 0.15 days/% TBSA burned vs 0.87 +/- 0.05 days/% TBSA burned, P < .05). We conclude that treatment using oxandrolone should be considered for use in the severely burned while hepatic transaminases are monitored.

Adolescent↗

PubMed2004

The long-term effect of oxandrolone on hepatic acute phase proteins in severely burned children.

BACKGROUND: Acute phase protein production is a hallmark of severe burns. We wondered whether anabolic treatment with oxandrolone would affect these proteins. METHODS: Thirty-five children with > or =40% total body surface area burns were randomized to receive either placebo or oxandrolone (0.1 mg/kg by mouth twice daily) from postoperative day 5 to 1 year postburn. Levels of constitutive proteins and acute phase proteins were measured at admission; at discharge; and at 6, 9, and 12 months after burn. Total albumin supplementation and hepatic transaminases were also assessed. RESULTS: Constitutive proteins such as albumin, prealbumin, and retinol-binding protein levels increased (p < 0.05), and acute phase proteins such as alpha 1-acid glycoprotein, C3 complement, alpha 2-macroglobulin, and fibrinogen levels significantly decreased in the oxandrolone group compared with placebo (p < 0.05). Albumin supplementation during the acute hospitalization was reduced in the oxandrolone group. Hepatic transaminases remained within normal levels. CONCLUSION: Treatment with oxandrolone in severe burns significantly increases constitutive protein and reduces acute phase protein levels.

Acute-Phase Proteins↗

PubMed1986

The effect of oxandrolone on the growth hormone response to growth hormone releasing hormone in children with constitutional growth delay.

The effect of treatment with oxandrolone, an anabolic steroid, on GH response to GH-releasing hormone (GHRH) has been evaluated in children with constitutional growth delay. Five subjects, four males and one female, aged 11.0-17.1 years were given oxandrolone 0.1 mg/kg p.o. daily for 2 months, and underwent acute administration of GHRH (GRF 1-40, 1 microgram/kg i.v.) before and after withdrawal of oxandrolone therapy. GHRH administration induced a much greater GH response, evaluated either as a peak plasma GH levels or plasma GH integrated area, after than it did before oxandrolone treatment. These findings indicate that in children with constitutional growth delay oxandrolone increases the sensitivity of somatotrophs to exogenous GHRH and, likely, to the endogenously-released neurohormone.

Adolescent↗

PubMed1988

Double blind placebo controlled trial of low dose oxandrolone in the treatment of boys with constitutional delay of growth and puberty.

Nineteen boys, mean age 14.4 years (range 12.9-16.3), with constitutional delay of growth and puberty were randomised into two groups in a double blind fashion for a three month period. Ten boys received oxandrolone, 2.5 mg per day (mean dose 0.072 mg/kg/day), and nine boys were treated with placebo. Mean growth velocity increased from 4.5 cm/year in the oxandrolone treated group to 9.6 cm/year in three months, and this was sustained at 8.6 cm/year after cessation of treatment. In the placebo treated group, growth rate showed no alteration from 5.1 cm/year to 5.2 cm/year; boys in this group were then treated with oxandrolone, 2.5 mg a day (mean dose 0.073 mg/kg/day) for three months and growth velocity accelerated to 8.6 cm/year. Serum concentrations of insulin-like growth factor -1/somatomedin-C (IGF-1) increased during oxandrolone treatment and continued to rise after treatment had ceased. There was no change in serum IGF-1 concentration during treatment with placebo. Oxandrolone, when used in an appropriate regimen, is an effective, safe treatment for boys with constitutional delay of growth and puberty.

Adolescent↗

PubMedDate not supplied

Body cell mass repletion and improved quality of life in HIV-infected individuals receiving oxandrolone.

BACKGROUND: The aim of this study was to measure changes in body cell mass (BCM) and quality of life in HIV-infected individuals undergoing oxandrolone therapy. Previous studies on oxandrolone have neither quantified changes in BCM using criterion methods nor quality of life using an HIV-specific instrument. METHODS: Twenty-five HIV-infected patients (15 with an AIDS diagnosis) on standard antiretroviral and nutrition management were studied before and an average of 18.6 weeks after the initiation of oxandrolone therapy, as prescribed by their primary care physician for the treatment of weight loss. BCM was estimated from intracellular water measured by multiple dilution. Lean soft tissue mass (LTM) was measured by dual-energy X-ray absorptiometry. Quality of life was evaluated by the Functional Assessment of HIV Infection (FAHI) questionnaire. RESULTS: Significant gains in body weight (2.6 +/- 3.0 kg; p < .0001), BCM (3.6 +/- 3.0 kg; p < .0001), and LTM (3.0 +/- 2.9 kg; p < .0001) occurred over an average course of 18.6 weeks of treatment. Overall quality of life improved (p = .056) and appetite improved (p = .032), both of which were positively associated with weight gain (p = .040 and p = .022, respectively). CONCLUSIONS: This is the first study involving oxandrolone therapy in HIV infection to document changes in quality of life and BCM, the metabolically active component of lean body mass that reflects nutritional status better than other more global body composition parameters. Nutritional status and quality of life can improve in HIV-infected individuals receiving a combined therapeutic approach that includes oxandrolone.

Adult↗

PubMed1989

Oxandrolone in constitutionally delayed growth, a longitudinal study up to final height.

Twenty-seven prepubertal boys and 9 prepubertal girls with constitutionally delayed growth were treated with the anabolic steroid oxandrolone for 12 months and followed until they reached final height. Sixteen boys were treated with a mean dose of 0.12 mg/kg.day [low dose (LD)] and 11 boys with a mean dose of 0.22 mg/kg.day [high dose (HD)]. The girls were treated with a mean dose of 0.1 mg/kg.day. Thirteen boys and 9 girls served as controls. On oxandrolone the mean height velocity increased from 4.0 to 8.6 (boys, LD), from 4.3 to 8.9 (boys, HD), and from 4.3 to 8.3 cm/yr (girls). The immediate posttreatment height velocity was significantly higher than the pretreatment height velocity (P less than 0.05), regardless of whether the patients had entered puberty. On oxandrolone the mean ratios of change in bone age/change in chronological age were 2.0 (boys, LD), 2.3 (boys, HD), and 2.0 yr/yr (girls) and continued to be accelerated during the 6 months after treatment. Height predictions at the onset of treatment and after 6 months off treatment were calculated by three different methods: Bayley-Pinneau (BP), Roche-Wainer-Thissen (RWT), and Tanner Mark II (T II). In the boys (LD) mean height predictions increased significantly by the methods of BP (3.3 cm) and RWT (2.9 cm), but not by the method of T II (0.6 cm). In the boys (HD) no significant change in height predictions was noted. In the girls mean height predictions remained unchanged by BP and RWT, but decreased significantly by T II (-2.5 cm). The difference between final height and initial height prediction was taken as a measure of the influence of the treatment on adult height. In all three treatment groups the difference between final height and initial height prediction, calculated with all three methods, did not differ from the control group. We conclude that oxandrolone treatment for 1 yr has no effect on adult height. In spite of this, the use of an anabolic steroid such as oxandrolone may still have value, as an increase in height velocity and an earlier onset of puberty may benefit short children suffering from psychological problems due to delay of growth and development.

Body Height↗

PubMed1996

Improved final height in girls with Turner's syndrome treated with growth hormone and oxandrolone.

The spontaneous growth process in Turner's syndrome is characterized by a progressive decline in height velocity during childhood and no pubertal growth spurt. Therefore, therapy aimed at improving height during childhood as well as increasing final height is desirable for most girls with Turner's syndrome. Forty-five girls with Turner's syndrome, 9-16 yr of age (mean age, 12.2 yr), were allocated to three study groups. Group 1 (n = 13) was initially treated with oxandrolone alone; after 1 yr of treatment, GH without (group 1a; n = 6) or with (group 1b; n = 7) ethinyl estradiol was added. Group 2 (n = 17) was treated with GH plus oxandrolone. Group 3 (n = 15) was treated with GH, oxandrolone, and ethinyl estradiol. The dosage were: GH, 0.1 IU/kg.day; oxandrolone, 0.05 mg/kg.day; and ethinyl estradiol, 100 ng/kg.day. A height of 150 cm or more was achieved in 61%, 75%, and 60% of the girls in groups 1, 2, and 3, respectively. The most impressive increase in height was seen in group 2. In this group the mean final height was 154.2 cm (SD = 6.6), which is equivalent to a mean net gain of 8.5 cm (SD = 4.6) over the projected final height. In group 3, in which ethinyl estradiol was included from the start of therapy, the initially good height velocity decelerated after 1-2 yr of treatment. Their mean final height was 151.1 (SD = 4.6) cm, equivalent to a mean net gain of 3.0 cm (SD = 3.8). A similar growth-decelerating effect of ethinyl estradiol was seen in group 1b. We conclude that in girls with Turner's syndrome who are older than 9 yr of age, treatment with GH in combination with oxandrolone results in significant growth acceleration, imitating that in normal puberty, leading to a more favorable height during childhood. This mode of treatment also results in a significantly increased final height, permitting a great number of the girls to attain a final height of more than 150 cm. However, early addition of estrogen decelerates the height velocity and reduces the gain in height.

Adolescent↗

PubMed1976

Studies of anabolic steroids: v. effect of prolonged oxandrolone administration on growth in children and adolescents with uncomplicated short stature.

A total of 130 patients with uncomplicated short stature (4 to 17 years of age) were treated with oxandrolone, 0.25 mg/kg/day, for up to four years. Oxandrolone therapy resulted in a two-fold increase in mean growth velocity in the first six months of therapy and was an effective growth stimulant for the full four-year period. There was no overall adverse effect of oxandrolone on post-treatment mean growth velocity or on skeletal maturation relative to height gain. There were 37 patients with greater increase in height age than bone age and 22 patients with greater increase in bone age than height age. Assessment of the contribution of oxandrolone therapy to the latter group is difficult because of inadequate methodology and the wide variation in individual growth patterns. Taken in their entirety, the data suggest that oxandrolone is useful in the prolonged treatment of uncomplicated short stature and is not associated with undesirable acceleration of skeletal maturation.

Adolescent↗

PubMed1981

Children with growth hormone deficiency. Intermittent treatment with somatropin and oxandrolone.

The effectiveness of a combination of somatropin (0.1 IU/kg in three doses per week) and oxandrolone (0.1 mg/kg/day) in the treatment of human growth hormone deficiency was evaluated. Twelve children with hypopituitarism were placed into two separate groups. Each group was treated for five 6-month periods, and anthropologic measurements and bone-age determinations were obtained at the end of each period. Both groups of children grew approximately 20 cm during the 30 months of treatment. Somatropin increased the growth rate significantly both when given alone and when given in combination with oxandrolone. Although the addition of oxandrolone may have diminished the waning effect often seen during somatropin therapy, the acceleration in bone age indicates the need for further long-term studies before oxandrolone can be recommended as an adjunct to treatment with somatropin.

Body Height↗

PubMed2006

Effects of oxandrolone, an anabolic steroid, on hemostasis.

This study evaluated the short-term effects of oxandrolone, an anabolic androgenic synthetic steroid, on blood coagulation and the hemostatic/fibrinolytic system in healthy individuals. Subjects (n = 14) were administered oxandrolone (10 mg twice daily) for 14 days. Blood was obtained on days 0, 1, 3, 7, 9, 14, and then at day 42 (28 days after discontinuation of the drug). Samples were analyzed for the plasma plasminogen, plasminogen activator inhibitor (PAI-1), fibrinogen, and coagulation factors (II, V, VII, VIII, and X). After 7 days of administration of oxandrolone, the plasma plasminogen level significantly increased [100% +/- 21% to 174% +/- 21% (P < 0.0001)]. PAI-1 was significantly decreased at day 3 [16 +/- 9 to 7 +/- 4 mg/dL (P < 0.01)]. Coagulation factors II and V significantly increased at day 14 [88 +/- 15 to 122 +/- 11 (P < 0.005) and 105 +/- 21 to 179 +/- 36% (P < 0.0001)], respectively. Factor VII level decreased by day 3 [91% +/- 26% to 83% +/- 18%, NS], but after 14 days factor VII level returned to baseline (91% +/- 26% to 93% +/- 19%, NS). The increase of factor VIII level was not significant (111% +/- 64% to 125% +/- 55%, NS). Factor X increased steadily over 14 days of drug treatment [96% +/- 11% to 107% +/- 25%, NS] and after discontinuation, decreased and returned to baseline by day 42 [107% +/- 25% to 89% +/- 25%, NS]. Fibrinogen decreased by 22% +/- 12%, (NS). Administration of oxandrolone, to healthy young men was associated with a significant increase in select blood coagulation factors and plasminogen. These changes create a state of potential hypercoagulability that appears to be counterbalanced by increased fibrinolytic activity to maintain homeostasis.

Adult↗

PubMed1997

Final height outcome in girls with Turner syndrome treated with a combination of low dose oestrogen and oxandrolone.

Final stature in girls with Turner syndrome treated with combination of low dose oestrogen and oxandrolone. Nineteen prepubertal girls with Turner syndrome (mean age 10.9 years, range, 8.9-14.2 years) were randomly assigned to receive either oxandrolone (0.05 mg/kg/day) or ethinyloestradiol (40 ng/kg/day) for 1 year. Subsequently the alternate therapy was added and the combination given until attainment of final height. Ethinyloestradiol was gradually increased at the age of 12.5 years in order to induce secondary sexual characteristics. The duration of treatment was a mean of 5.2 years (range, 3.7 years) when the 1st year of monotherapy was included. Therapy produced a sustained acceleration in growth rate for a duration of 4 years and eventually has resulted in an increment of mean adult height of 3 cm relative to pre-treatment projected height with mean values of 146.5 cm versus 143.5 cm respectively. The moderate side-effects observed did not cause any of the girls to discontinue treatment. Nevertheless, amelioration of adult height appears to be modest, notably in comparison to published data of growth hormone treatment and 4 girls had a decrease in final height prediction. CONCLUSION Combination of low dose of oxandrolone and oestrogen may have a moderate but positive impact on final height in girls with Turner syndrome. However, some girls do worse than predicted in term of final height using this regimen. Oestrogen therapy started at low dose around the age of 10 years and increased gradually at approximately 12.5 years to induce secondary sexual characteristics does not have a deleterious effect on adult height in Turner syndrome. In summary, low dose oxandrolone-oestrogen treatment was found to accelerate the tempo of growth in girls with Turner syndrome, but did not appear to have a consistent effect on final height.

Adolescent↗

PubMed1980

The combined effect of growth hormone and oxandrolone in patients with growth hormone deficiency.

Twenty patients with growth hormone deficiency ranging in age from 5 5/12 to 15 8/12 years were treated for 12 months with a combination of human growth hormone and oxandrolone, followed by a period of six months off both medications. Eight of the patients received the combined therapy during the first year of hGH treatment, and 12 during either the second or fourth years of hGH administration. In considering growth velocity alone, the addition of anabolic steroid was beneficial. The bone age advanced rapidly when oxandrolone was added during the first year of hGH treatment, and less rapidly in subsequent years. The increased growth velocity, however, compensated for the acceleration of bone maturation and the overall effect of the combined treatment was beneficial, particularly when used after the first year of hGH treatment. We conclude that there is no advantage to using oxandrolone during the first year of hGH therapy, that oxandrolone in the appropriate dose is of benefit in subsequent years of hGH treatment, and that because of the individual variation in bone maturation, bone age should be frequently assessed.

Adolescent↗

PubMed1984

Short-term and long-term survival in patients with alcoholic hepatitis treated with oxandrolone and prednisolone.

A cooperative study was conducted to determine the efficacy of 30 days of treatment with either a glucocorticosteroid (prednisolone) or an anabolic steroid (oxandrolone) in moderate or severe alcoholic hepatitis. One hundred thirty-two patients with moderate disease and 131 with severe disease were randomly assigned to one of three treatments: prednisolone, oxandrolone, or placebo. During the 30 days, mortality in the groups receiving steroid therapy was not significantly different from mortality in the placebo group. Thirteen per cent of the moderately ill patients and 29 per cent of the severely ill patients died. Although neither steroid improved short-term survival, oxandrolone therapy was associated with a beneficial effect on long-term survival. This was especially true in patients with moderate disease: among those who survived for one or two months after the start of treatment the conditional six-month death rate was 3.5 per cent after oxandrolone and 19 to 20 per cent after placebo (P = 0.02). No consistent long-term effect was associated with prednisolone therapy.

Clinical Trials as Topic↗

PubMed2000

HIV-associated wasting: brief review and discussion of the impact of oxandrolone.

This is a brief review of human immunodeficiency virus (HIV)-associated wasting with expanded discussion of one treatment agent, oxandrolone. HIV-associated wasting is the involuntary loss of more than 10% of baseline body weight in the presence of chronic diarrhea, weakness, or fever lasting longer than 30 days. For patients, this clinical syndrome has special importance because it affects not only their survival but also their physical appearance and social interactions. Pharmacologic treatment is only one of the many approaches that need to be explored in every patient who presents with this condition. In 1964, oxandrolone became the first drug approved for the treatment of wasting. Since then its role has expanded to HIV-associated wasting. As an anabolic agent oxandrolone reverses many of the metabolic abnormalities characteristic of HIV-associated wasting leading to dose dependent increase in nitrogen retention. Similar to many other HIV treatments, gaps exist in our knowledge of the role of oxandrolone in HIV-associated wasting. These gaps will be filled only by years of field exposure and further clinical research.

Anabolic Agents↗

PubMed2003

Gene expression patterns in skeletal muscle of thermally injured children treated with oxandrolone.

OBJECTIVE: To analyze gene expression patterns in skeletal muscle from burned children. SUMMARY BACKGROUND DATA: Analysis of gene expression patterns in skeletal muscle from burned children can help provide a fundamental understanding of muscle wasting at the molecular level. This study is the first to use such an approach in burned children receiving anabolic treatment. METHODS: Children who received 0.1 mg/kg oxandrolone twice a day (n = 7) were compared to placebo (n = 7). Net protein balance was determined before and after treatment with oxandrolone. Total RNA, extracted from muscle biopsies obtained from burned children age 3 to 18 years, was purified, reverse transcribed, and biotinylated cRNA hybridized to the human high-density oligonucleotide array (U95Av2). Western blot analysis verified the mRNA changes at their protein level. RESULTS: DNA microarray analysis showed two genes significantly changed in muscle from burned children receiving placebo, while the expression of 21 genes was altered with oxandrolone. Muscle net protein balance increased with oxandrolone treatment compared to placebo. CONCLUSIONS: DNA microarray technology will help identify molecular changes that can serve as targets for new therapies to attenuate muscle wasting in severely burned children and thus improve recovery and early rehabilitation.

Adolescent↗

PubMed1988

Growth and growth hormone responses to oxandrolone in boys with constitutional delay of growth and puberty (CDGP).

Thirteen boys with constitutional delay in growth and/or development aged 7.6 to 16 years received 2.5 mg/day of oxandrolone for 3 months. Their growth response on treatment and in the subsequent 3 months was compared to that of 14 age-matched untreated controls. Growth rates were analysed in groups arbitrarily defined by testicular volume at entry (less than 4 ml prepubertal, greater than 4 ml pubertal). Growth velocities increased on oxandrolone (prepubertal, mean 4.4 to 7.5 cm/year, P = 0.05: pubertal, mean 4.7 to 8 cm/year, P less than 0.05). Over the next 3 months, the pubertal boys grew at 9.3 cm/year, while the prepubertal group decelerated to 6.2 cm/year. Both control groups showed no significant change in velocity over 6 months. GH responses to arginine and GRF, and to sleep in prepubertal boys, were unchanged throughout the study. However, in pubertal boys the mean GH levels ('area under the curve') during sleep at 3 and 6 months, had increased over baseline values, associated with a significant increase at 6 months in basal somatomedin-C (140 to 214 ng/ml, P less than 0.05). Oxandrolone does not alter the GH status of prepubertal boys, and thus probably promotes growth by a direct action at the growth plate. In contrast, the persistent growth acceleration of pubertal boys may be associated with increased GH and somatomedin-C levels: in this group, oxandrolone has proved a useful stimulus to growth.

Adolescent↗

PubMed1991

Treatment of constitutional growth delay in prepubertal boys with a prolonged course of low dose oxandrolone.

Forty six prepubertal boys who had constitutional growth delay were treated with oxandrolone. Mean age at the onset of treatment was 11.9 years (range 9.0-14.0) and bone age delay was 1.9 'years'. The dose of oxandrolone used was a mean of 0.05 mg/kg (range 0.03-0.18) for a mean of 0.9 years (range 0.2-3.6). Height velocity increased from a mean (SD) before treatment of 4.0 (1.0) to 7.5 (1.2) cm/year with oxandrolone. Growth rate was sustained at 7.6 (2.2) cm/year in the period after treatment. Those boys who attained a testicular volume of 4 ml or greater at the end of the treatment period had the most pronounced sustained growth acceleration. Height for bone age SD score did not alter significantly from a mean of -1.0 before treatment to -1.2 after treatment. Oxandrolone is a safe and effective treatment for prepubertal boys with constitutional growth delay.

Adolescent↗