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PubMed1998

Induction of early puberty in a boy after treatment with oxandrolone?

We report on a 9-year-old boy with early puberty who had been treated with oxandrolone because of constitutional delay of growth. Treatment was started at the age of 6.25 years. During the treatment with oxandrolone over 22 months, the height velocity increased above the 97th percentile, and bone age developed twice as fast as chronological age. After discontinuing the medication, the growth velocity did not decrease, and the bone age still accelerated. When he was 9.1 years old, testicular volume had increased to 12 ml, pubic hair stage had progressed and he developed a mild facial acne. We hypothesize that oxandrolone could have induced an early onset of puberty in this boy. We conclude that treatment with oxandrolone in young children should be considered carefully and be used for short periods only. Potential side effects might include the rapid acceleration of puberty and skeletal maturation.

Age Determination by Skeleton↗
PubMed1996

Insulin, insulin-like growth factor-binding protein-1, and sex hormone-binding globulin in patients with Turner's syndrome: course over age in untreated patients and effect of therapy with growth hormone alone and in combination with oxandrolone.

We have studied the course over age of fasting insulin, sex hormone-binding globulin (SHBG), and insulin-like growth factor (IGF)-binding protein-1 (IGFBP-1) in untreated children with Turner's syndrome (TS) and measured the course of these parameters during therapy with GH alone and in combination with oxandrolone. Forty patients with TS, aged 3.7-16.4 yr, were investigated before any therapy. Fasting insulin levels increased significantly with chronological age, whereas SHBG and IGFBP-1 decreased with chronological age, and serum concentrations of these parameters were in the normal range. SHBG and IGFBP-1 were not coregulated by insulin in TS as previously reported under physiological conditions; IGFBP-1 was inversely correlated with insulin, but SHBG was not, and neither parameter was correlated with the other. Twenty-eight patients were further investigated 3, 6, 9, and 12 months after the start of GH monotherapy (12-18 IU/m2-week) and 3, 6, 9, and 12 months after the addition of oxandrolone (0.0625 mg/kg.day; n = 16). There was a significant increase in insulin levels during GH monotherapy and a further increase during combination therapy, with peak levels 3 months after the start of GH and combination therapy, respectively. Both SHBG and IGFBP-1 levels decreased significantly during GH monotherapy, with a further dramatic decrease after the addition of oxandrolone. Levels of free testosterone were unaffected by both treatment regimens. IGFBP-1 was inversely correlated with insulin concentrations at all time points after the start of therapy. SHBG was inversely correlated with IGF-I concentrations, but showed no relation to insulin concentrations during GH monotherapy. In conclusion, there were no abnormalities in serum concentrations of insulin, SHBG, and IGFBP-1 in untreated patients that could help to explain the retarded growth in patients with TS. All effects of combined GH and oxandrolone therapy on endocrine parameters such as insulin, SHBG, IGFBP-1 and IGF-I mimic the endocrine pattern normally observed during the pubertal growth spurt. Our data confirm the importance of insulin in the regulation of IGFBP-1, but do not point to a coregulation of IGFBP-1 and SHBG by insulin in patients with TS.

Adolescent↗
PubMed2002

Reversal of COPD-associated weight loss using the anabolic agent oxandrolone.

STUDY OBJECTIVE: Weight loss is a common complication of COPD, associated with negative outcomes. Weight restoration has been associated with improved outcomes. The effects of oxandrolone, an adjunct to help restore weight, were evaluated in patients with COPD. DESIGN: Prospective, open-label, 4-month clinical trial. SETTING: Twenty-five community-based pulmonary practices throughout the United States. PATIENTS: A primary pulmonary diagnosis of moderate-to-severe COPD as defined by FEV1 < 50% of predicted and FEV1/FVC ratio < 0.7, along with significant involuntary weight loss (weight < or = 90% ideal body weight). INTERVENTIONS: Oral oxandrolone, 10 mg bid. MEASUREMENTS AND RESULTS: Body weight, body composition (bioelectric impedance analysis), spirometry, and 6-min walking distance were measured. Data for 82 patients at 2 months and 55 patients at 4 months are presented. At month 2, 88% of patients had gained a mean +/- SD of 6.0 +/- 4.36 lb (p < 0.05) and 12% had lost a mean of 1.7 +/- 2.15 lb (not statistically significant [NS]). At month 4, 84% had gained a mean of 6.0 +/- 5.83 lb (p < 0.05) and 16% had lost a mean of 1.8 +/- 1.74 lb (NS). Month 4 bioelectric impedance analysis showed the weight to be primarily lean tissue, with a mean increase in body cell mass of 3 +/- 2.6 lb (p < 0.05), and a mean increase in fat of 1.2 +/- 4.6 lb (NS). CONCLUSIONS: Oxandrolone is an effective adjunct to facilitate weight restoration in patients with COPD-associated weight loss. Weight gain is primarily lean body mass. Oxandrolone was relatively well tolerated and, therefore, should be a consideration in the comprehensive management of patients with COPD and weight loss.

Aged↗
PubMed2001

The anabolic steroid oxandrolone increases muscle mass in prepubertal boys with constitutional delay of growth.

The aim of this study was to investigate the effect of oxandrolone on body composition in boys with constitutional delay of growth and puberty. In 14 prepubertal boys, height, weight, triceps and subscapular skinfolds and upper arm circumference were measured. Body mass index, the ratio of subscapular to triceps skinfolds and the upper muscle area were also determined. The difference of the various measurements and indices, 3 to 6 months before and after commencement of oxandrolone treatment, were calculated, while the boys remained prepubertal. We observed a marked increase in body mass index, a decrease of triceps and subscapular skinfolds, an increase in the ratio of subscapular to triceps skinfolds and also an increase in upper muscle area after the onset of oxandrolone treatment. These results suggest that low dose oxandrolone administration in prepubertal boys with constitutional growth delay causes a disproportionate increase of weight to height which is largely due to increased body muscle.

Anabolic Agents↗
PubMed1992

The effects of an anabolic steroid (oxandrolone) on reproductive development in the male rat.

Oxandrolone is a 5 alpha-reduced anabolic steroid that is administered for the treatment of short stature disease in children. It is a commonly used substance beginning as early as prepuberty by some individuals who are seeking to enhance athletic performance or personal appearance. Because of the lack of data on the effects of anabolic steroids on the reproductive system, we have examined the effects of oxandrolone treatment on reproductive development in male rats with treatment beginning two days after weaning. Male, Sprague-Dawley rats (N = 12) received a daily subcutaneous injection of oxandrolone (32.7 mumol.kg-1.day-1) and the control group (N = 12) received vehicle only (dimethyl sulfoxide). Treatment began at age 23 days and continued to 60 days of age. The weights of the testes, prostate glands, and seminal vesicles in the treatment group were 69%, 50% and 29% below control levels, respectively and were all significantly decreased (p less than 0.01). Testicular testosterone production in a 3-h incubation was inhibited in the treated animals to 1.3% of control values (p less than 0.001). Serum FSH (11.7% of control) and LH (undetectable) in the treated animals were both significantly less than controls. Histological findings indicated an arrest of advanced spermatids and a severe depletion of Leydig cells in the interstitial compartment. It was concluded that treatment of immature male rats with oxandrolone results in effects on the adult male reproductive system which are profound and occur at several levels. The most likely affected sites are the hypothalamus, pituitary gland, and the Leydig cells.

Animals↗
PubMed1999

Evaluation of the effects of oxandrolone on malnourished HIV-positive pediatric patients.

OBJECTIVE: To determine the safety and efficacy of anabolic therapy to prevent or reverse wasting and malnutrition in human immunodeficiency virus (HIV)-infected pediatric patients. The anabolic steroid, oxandrolone, was evaluated because of its safe and effective use in other pediatric conditions. METHODS: Nine HIV-positive children who were malnourished or at risk for malnutrition (4 females, 5 males; 4-14 years of age) took oxandrolone for 3 months (.1 mg/kg/day orally). Quantitative HIV ribonucleic acid polymerase chain reaction and CD4(+) T-cell levels, complete blood cell count (CBC) and chemistry profile, endocrinologic studies, resting energy expenditure, respiratory quotient, nutritional measures, body composition assessment with quantitative computed tomography, and skinfold body composition measurements were determined before treatment, during treatment (3 months), and for 3 months after treatment. Statistical analyses were completed using the Friedman two-way analysis of variance and Spearman correlation tests. RESULTS: No adverse clinical or laboratory events or changes in Tanner staging or virilization occurred. Quantitative HIV ribonucleic acid polymerase chain reaction and CD4(+) T-cell levels did not change significantly. Insulin-like growth factor 1 increased, suggesting an anabolic effect of treatment. The rate of weight gain increased during treatment and was maintained after treatment. Linear growth continued and was maintained throughout treatment, whereas bone age did not increase significantly. Anthropometric assessments indicated an increase in muscle mass and a decrease in fat while patients were on treatment, and a mild decrease of muscle and increased fat posttreatment. Likewise, computed tomography scan results demonstrated similar changes in muscle mass. Resting energy expenditure and respiratory quotient remained stable throughout treatment and follow-up. No significant changes were seen in the quality of life questionnaire. CONCLUSIONS: Treatment with oxandrolone for 3 months in HIV-infected children was well-tolerated, safe, and associated with markers of anabolism. The latter effect was maintained partially for 3 months after discontinuation of a 3-month course of therapy. Additional studies are needed to assess the potential benefits and risks of a longer course of therapy or a higher dose of oxandrolone in HIV-infected children.

Adolescent↗
PubMed1975

Hepatic fine structure in young and aging rats treated with oxandrolone: a morphometric study.

Hepatic fine structural alterations induced by shortterm administration of the hypolipidemic drug oxandrolone were evaluated using morphometric techniques. These changes are described in the livers of normolipidemic young adult and hyperlipidemic retired breeder male rats. Retired breeder rats, characterized by hyperlipidemia and a high incidence of arteriosclerosis, are thought to undergo premature aging. A previous morphometric study has shown that the hepatocytes of retired breeder rats are larger, contain a greater volume fraction of lysosomes, and have significantly less smooth-surfaced endoplasmic reticulum than those of young adult rats. However, after oxandrolone administration, the livers of these two animal groups were no longer distinguishable on the basis of these morphometric parameters. Unlike a number of other hypolipidemic drugs, oxandrolone does not induce a marked proliferation of hepatic microbodies. The effect of oxandrolone on the livers of prematurely aging rats suggests that the age-related fine structural changes are not the result of irreversible alterations in the genome or translation-transcription apparatus but may actually represent secondary reactions to extrahepatic and/or endocrine metabolic changes. The relationship between (1) aging and hyperlipidemia and (2) aging and the reduced hepatic capacity to metabolize drugs suggest a need to evaluate the effects of lipid-lowering drugs on the livers of old as well as young animal models.

Age Factors↗
PubMed1975

Efficacy and interactions of oxandrolone, halo-fenate and clofibrate in a factorial study on experimental acute nephrotic hyperlipidemia.

Nephrotic mixed hyperlipidemia may be associated with accelerated coronary artery disease. To investigate the response of experimental nephrotic hyperlipidemia to therapy, a 2(4) factorial study of sodium clofibrate and beta-benzalbutyrate, halofenate and oxandrolone (250, 150, 100 and 10 mg/kg/day, respectively) was carried out. Nephrotic syndrome was induced by a single i.p. injection of puromycin aminonucleoside (90 mg/kg) in 80 female white rats of average weight 160 g. Oxandrolone proved to be significantly hypotriglyceridemic in combined therapy (average fall, 38%; P less than .05), and also lowered serum total cholesterol and phospholipid concentrations (23% and 21% falls, P less than .01) and less than .05), due largely to synergistic interactions with clofibrate-like drugs. Hypocholesteremic effects (23 and 22% average falls) were also significant for halofenate (P less than .01) and clofibrate (P less than .05) . Serum triglyceride levels actually rose significantly (P less than .05) with drug combinations containing beta-benzalbutyrate. Clofibrate and its analogs (halofenate and beta-benzalbutyrate) produced significant hepatomegaly (mean responses of +18, +18 and +10%, respectively) whereas oxandrolone produced significant hepatic shrinkage (-10%)(P less than .05). Secondary effects (drug interactions) were also found; hypotriglyceridemic synergism (effects more than additive) occurred between oxandrolone and clofibrate or its analogs (P less than .05), whereas antagonism (effects less than additive) was observed within the clofibrate-like group (P less than .01 or less .05).

Animals↗
PubMed1978

A long-term study of the efficacy of oxandrolone in hyperlipoproteinemias.

Oxandrolone, an anabolic steroid, significantly reduced serum triglycerides in type III, IV, and V hyperlipoproteinemia, with a concomitant decrease in pre-beta lipoproteins. Its slightly enhancing effect on serum cholesterol and absolute increase in beta lipoproteins might eventually discourage its administration in type II patients. Alpha lipoproteins always remained at low levels. In addition to its hypotriglyceridemic action,, oxandrolone induced a slight reduction in uric acid and alkaline phosphatases. Untoward side effects were not observed even after prolonger therapy. Therefore, oxandrolone might deserve a place among the few available triglyceride-reducing therapies.

Adolescent↗
PubMed2005

Final height in a patient with Laron syndrome after long-term therapy with rhlGF-I and short-term therapy with LHRH-analogue and oxandrolone during puberty.

OBJECTIVE: To report our experience on long-term treatment with recombinant-human-IGF-I (rhIGF-I) of a female patient with Laron syndrome (mutation G223G in the GH receptor gene), who received short-term treatment (1 yr) with LHRH analogue at the start of puberty and subsequently with oxandrolone. CASE REPORT: The patient started IGF-I therapy (dose 40 microg/kg bid for 9 months, 80 microg/kg bid until 13.7 yr of age and 120 microg/kg bid thereafter) when she was 7.6 yr old (height -6 sds), and was treated for 9.4 yr until final height (cm 129.7; -5.5 sds). At first signs of puberty (age 12.7 yr; height 116.3; -5.3 sds), LHRH analogue was started (3.75 mg/28 days) and bone age progressed by 6 months in the 12-month period. Growth velocity decreased in the 6-12th month of combined treatment (0.9 cm/6 months), and treatment was suspended. At age 14.8 (height 124.5; -6.6 sds), oxandrolone was added (0.1 mg/kg/day), but after 12 months (height 128 cm; -5.7 sds) bone age increased from 11.5 to 13.5 yr and the drug was stopped. No side effects occurred during the various treatments. Body segments progressed harmonically: there was a tendency towards improvement in the upper to lower body segment ratio and in cranial growth. Only biiliac diameter did not increase during LHRH treatment. During the 9-yr period, body mass index (BMI), subscapular and triceps skinfold centiles did not show any significant variations. CONCLUSIONS: Our patient with Laron syndrome after long-term treatment showed a final result below the initial expectations, confirming that IGF-I used with the present schedule is less effective than GH in GH-deficient patients. LHRH analogue therapy at puberty was associated with a slower bone age maturation but with an almost complete arrest of growth. On the contrary, oxandrolone sustained growth but caused an excessive maturation of bone age. Other strategies are necessary to improve final height in these patients.

Age Determination by Skeleton↗
PubMed1993

Oxandrolone in constitutional delay of growth: analysis of the growth patterns up to final stature.

In order to evaluate the effects of low-dosage, 6-12 months course of oxandrolone treatment in constitutional delay of growth, we compared the growth responses on treatment, the pattern of sexual development and pubertal growth events, up to final stature of 11 prepubertal boys, aged 10.6-14.1 yr, with those of 11 prepubertal, age-matched untreated controls. Treatment caused a significant increase of height velocity, from 4 to 9 cm/yr, and a significant acceleration of bone maturation, without affecting the timing of onset of puberty, the progression of sexual development or the onset of pubertal growth spurt. On the other hand, oxandrolone induced an earlier skeletal growth arrest but did not affect the expected final height. Treated boys showed an adult stature not significantly different from that of control subjects. Our data suggest that 6 months-1 year, low dosage oxandrolone treatment in constitutionally delayed growth has no significant effect on the pattern of pubertal growth, nor on the rate of sexual maturation or on final height.

Adolescent↗
PubMed1997

Effect of low dose oxandrolone and testosterone treatment on the pituitary-testicular and GH axes in boys with constitutional delay of growth and puberty.

OBJECTIVE: To investigate the effect of low dose oxandrolone and testosterone on the pituitary-testicular and GH-IGF-I axes. DESIGN: Prospective double-blind placebo-controlled trial. PATIENTS: Sixteen boys with constitutional delay of growth and puberty (CDGP) with testicular volumes 4-6 ml were randomized to 3 months treatment: Group 1 (n = 5), daily placebo: Group 2 (n = 5), 2.5 mg oxandrolone daily or Group 3 (n = 6), 50 mg testosterone monthly intramuscular injections with assessment (growth, pubertal development and overnight hormone profiles) at 0, 3, 6 and 12 months. MAIN OUTCOME MEASURES: LH and GH profiles (15-minute samples) were analysed by peak detection (Pulsar), Fourier transformation and autocorrelation. Testosterone levels were measured hourly and insulin, SHBG, IGF-I, and IGFBP-3 levels at 0800 h. Statistical analysis was by multivariate analysis of variance for repeated measures. RESULTS: LH and testosterone parameters increased significantly with time in all 16 (LH AUC, P < 0.001; peak amplitude, P = 0.02; number of peaks, P = 0.02; testosterone AUC, P = 0.02; morning testosterone, P = 0.002). In Group 2, however, LH and testosterone parameters decreased at 3 months followed by a rebound increase at 6 and 12 months. SHBG levels were markedly reduced at 3 months (P = 0.006) and a wider range of dominant GH frequencies was present although GH AUC was not increased until 6 months, with an increase in GH pulse frequency but not amplitude. IGF-I levels were increased at both 3 and 12 months. In Group 3, pituitary-testicular suppression was not apparent, but GH levels increased with an increase in GH amplitude at 3 and 12 months. CONCLUSION: Oxandrolone transiently suppressed the pituitary-testicular axis and altered GH pulsatility. Testosterone increased GH via amplitude modulation.

Adolescent↗
PubMedDate not supplied

Effect of testosterone and oxandrolone on thrombocyte aggregation and synthesis of prostaglandins in thrombocytes and aorta of atherosclerosis-susceptible pigeons.

Effect of intramuscular administration (10 mg/kg/week) of testosterone and oxandrolone on a) thrombocyte aggregation and b) synthesis of prostaglandins from [14C]-arachidonic acid in thrombocytes and aorta of atherosclerosis-susceptible White Carneau pigeon was examined. Neither testosterone nor oxandrolone influenced collagen, ADP and arachidonic acid induced aggregation or the synthesis of prostaglandins in thrombocytes. However, both testosterone and oxandrolone stimulated (p less than 0.05) the synthesis of 6-keto-PGF1 alpha (stable product of prostacyclin) und PGE2 in aorta.

Animals↗
PubMed1990

Oxandrolone increases final height in Turner syndrome.

In order to examine whether the anabolic steroid oxandrolone has any long-term effect on height in Turner syndrome, the short- and long-term effects were studied in a group of 35 individuals with the syndrome. At commencement of treatment, age range was 8.2-16 years (mean 12.9); oxandrolone dosage was 0.07-0.26 mg/kg per day (mean 0.14 mg/kg per day) and continued for 12 months-6 years (mean 33 months), ending at 12-18.5 years (mean 15.6 years). Height velocity increased significantly on therapy from 3.3 +/- 0.1 to 5.8 +/- 0.3 cm/year at 6 and 12 months, and maintained at 4.8 +/- 0.3 cm/year by two years (all P less than 0.001). Girls who were younger and whose bone age was delayed grew faster (P less than 0.001). Oxandrolone dose correlated with height velocity at 12 (r = 0.39, P less than 0.05) and 18 months (r = 0.31, P less than 0.05). Both height standard deviation score (SDS) and estimated mature height (EMH) increased significantly by the end of treatment (-0.31 +/- 0.2 to 0.45 +/- 0.2, and 140.4 +/- 1.1 cm to 144.4 +/- 1.1 cm respectively (both P less than 0.0001). In 23 patients who had completed growth at a mean age of 20.6 +/- 0.83 years, final height was 145.5 +/- 1.3 cm. This was not significantly different from EMH of 144.9 +/- 1.3 cm at the end of therapy, and based on a pre-treatment EMH of 140.5 +/- 1.3 cm, represented a mean height gain of 5 cm.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed2002

A pilot randomized trial of oxandrolone in inclusion body myositis.

BACKGROUND: Inclusion body myositis (IBM) remains without effective therapy. As anabolic steroids have myotrophic properties, the authors studied whether a synthetic androgen, oxandrolone, would have efficacy in IBM. METHODS: A double-blind, placebo-controlled, crossover design was used. Patients received oxandrolone or placebo for 12 weeks followed by a minimum 2-month washout period, followed by 12 weeks of the alternative treatment. Maximal voluntary isometric contraction testing (MVICT), manual muscle testing (MMT), and functional performance testing were obtained before and after each treatment period, with the whole-body MVICT score as the primary outcome measure. RESULTS: Of 19 patients enrolled, 16 (14 men, 2 women; median age 68.5 years) had complete data for at least the first treatment period, with 13 completing the entire study. Whole-body MVICT improved by a median of 15.5 kg with drug and 4.1 kg with placebo (p = 0.06), whereas MMT demonstrated a median increase of 2.0 Medical Research Council points with drug and 0.9 point with placebo (p = 0.33). Upper-extremity MVICT demonstrated a significant treatment effect, with strength increasing a median 6.3 kg with drug vs 2.5 kg with placebo (p = 0.006). Stair climbing also increased a median of 1 step on average with drug versus no change with placebo (p < 0.001). Minimal adverse effects occurred. CONCLUSIONS: Oxandrolone had a borderline significant effect in improving whole-body strength and a significant effect in improving upper-extremity strength as measured by MVICT. Given these findings, further study of this drug, possibly in combination with an immunomodulating agent, is warranted.

Aged↗
PubMed2005

[Carbohydrate metabolism in patients with Turner syndrome. The effect of therapy with growth hormone, oxandrolone and a combination of both].

UNLABELLED: Insulin resistance or the impairment of insulin capability to decrease blood glucose levels is seen in approximately 25% of girls with Turner syndrome (TS). Growth hormone (hGH), especially when administered at pharmacological doses, may additionally negatively affect the carbohydrate metabolism in TS girls, changing the response of peripheral tissues to insulin. The aim of the report was the assessment of glucose and insulin release and the prevalence of insulin resistance in physiological conditions (baseline and post-standard meal values), as well as after oral and IV glucose tolerance test in patients with Turner syndrome after a 6-month therapy with growth hormone, oxandrolone (Ox) and a combination of these two agents (hGH+Ox). The authors also evaluated the effect of these three therapeutic methods on carbohydrate metabolism, attempting to define the risk of glucose intolerance, type 2 diabetes and hyperinsulinemia and insulin resistance. The analysis of individual results in all the patients revealed that laboratory criteria for diagnosis type 2 diabetes (glycemia at 120 min OGTT >12.2 mmol/l) were met by one patient subjected to a combined therapy. Glucose intolerance (IGT) in OGTT, normally seen in 12.5% of untreated girls, was not intensified following a 6-month hGH or Ox therapy, but was more pronounced in patients on the combined treatment. A tendency was seen towards fasting hyperinsulinism (>25 uLI/ml) in patients on hGH and hGH+Ox, with more pronounced insulin resistance (IR1<7, IR2>5) in girls on the combined therapy. CONCLUSIONS: Combined treatment with growth hormone and oxandrolone results in a significant increase of insulin secretion and increased insulin resistance. In view of the effects of insulin resistance, one should analyze the advisability of combined treatment with growth hormone and oxandrolone in girls with Turner syndrome.

Adolescent↗
PubMed1979

Effects of oxandrolone on plasma lipoproteins in patients with type IIa, IIb and IV hyperlipoproteinemia: occurrence of hypo-high density lipoproteinemia.

The effects of oxandrolone on plasma lipids and lipoprotein composition in patients with type IIa, IIb and IV hyperlipoproteinemia were investigated. Oxandrolone (4 mg/day, for 28 days) induced a significant reduction in plasma and VLDL triglyceride. Reciprocal elevation of LDL cholesterol was observed in 8 of 10 type IV patients and in 2 of 5 type IIb patients. In patients with type IV hyperlipoproteinemia, significant reduction of plasma apolipoproteinB and VLDL apolipoprotein B and inverse LDL apolipoprotein B increment was observed after treatment with oxandrolone. HDL cholesterol was decreased. Hypo-high density lipoproteinemia defined as HDL cholesterol concentration below 40 mg/100 ml occurred in 7 of 10 type IV, 3 of 6 type IIb and 1 of 4 type IIa patients.

Adult↗