Bone Mineral Density, Bone Microarchitecture and Vertebral Fractures in Male Patients with Alcohol Use Disorders.

AIM: To investigate abnormalities in bone mineral density, trabecular bone score and vertebral fractures in male patients with alcohol use disorder to understand the impact on bone health. METHODS: The study subjects included 134 male patients. Controls were 134 age matched healthy males. Assessments were made of the bone mineral density (BMD), trabecular bone score (TBS) and vertebral morphometry (VFA) for vertebral fractures. Biochemical measurements included serum total T4, thyroid stimulating hormone (TSH), parathyroid hormone (PTH) and 25- Hydroxyvitamin D 25(OH) D. RESULTS: The mean BMD at total forearm, proximal forearm (or distal 1/3) and mid forearm was significantly higher in the alcohol use disorders (AUD) group than the controls (P < 0.01). Around 15% of patients with AUD had VFs compared with 9.0% of the healthy controls (P = 0.19). For each kg/m2 gain in body mass index (BMI), lumbar spine and total hip BMD increased by 0.009 and 0.014 g/cm2, respectively. Lumbar and hip BMD decreased by 0.002 and 0.003 g/cm2 per year increase in duration of alcohol used. For every 5 years increase in age of the patients the odds of having VFs increased by 39% (odds ratio 1.393 [95% confidence interval = 1.031-1.881, P = 0.03]). CONCLUSION: The findings of the current study suggest that persons with AUD in third and fourth decades of life, with BMI in normal range and with alcohol use disorder duration of around one decade might have no major alteration in BMD and TBS. Impact of alcohol use in this population was manifest by marginal increase in the prevalence of mild grade of vertebral fractures, mostly in the thoracic region.

Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.

OBJECTIVE: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.