Can injectable abaloparatide reduce fractures?

September 7, 2016

A new study looks at the efficacy of injectable abaloparatide on reducing fractures due to osteoporosis. Plus: Does acetaminophen use during pregnancy increase the risk of behavior problems in children?

According to results of a recent study published in JAMA, use of subcutaneous abaloparatide may reduce fractures in postmenopausal women with osteoporosis.

The study was a phase 3, double-blind, randomized control trial that ran from March 2011 to October 2014 at 28 sites in 10 countries. Postmenopausal women with bone mineral density (BMD) T scores ≤ −2.5 and > −5.0 at the lumbar spine or femoral neck and radiological evidence of ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture or a history of any low-trauma nonvertebral fracture within the past 5 years were eligible to be included. Participants were assigned to daily subcutaneous injections of blinded placebo (n = 821); abaloparatide, 80 μg (n = 824); or open-label teriparatide, 20 μg (n = 818) over the course of 18 months.

Related: Are bisphosphonates actually effective?

Overall 2463 women (average age, 69 years [range, 49-86]) enrolled and 1901 completed the study. New morphometric vertebral fractures happened in 0.58% (n = 4) of the abaloparatide group; 4.22% (n = 30) of the placebo group (risk difference [RD] vs placebo, −3.64 [95% confidence interval {CI}, −5.42 to −2.10]; relative risk, 0.14 [95% CI, 0.05-0.39]; P < .001); and 0.84% (n = 6) in the teriparatide group. The Kaplan-Meier estimated event rate was 3.3% for teriparatide; 2.7% for abaloparatide; and 4.7% for placebo (RD, −2.01 [95% CI, −4.02 to −0.00]; hazard ratio, 0.57 [95% CI, 0.32-1.00]; P = .049). Increases in BMD were greater with abaloparatide than with placebo (all P < .001). Incidence of hypercalcemia was lower with abaloparatide (3.4%) than with teriparatide (6.4%) with an RD of -2.96 (95% CI, −5.12 to −0.87; P = .006).

The researchers concluded that subcutaneous abaloparatide, when compared to placebo, reduced  risk of new fractures over 18 months. They urged further research to understand the clinical importance of RC, the risk versus benefit profile of abaloparatide treatment, and to compare the efficacy of abaloparatide to other treatments.

NEXT: Does in utero exposure to acetaminophen increase the risk of behavior problems in children?

 

Does in utero exposure to acetaminophen increase behavior problems in children?

Exposure to acetaminophen while in utero may increase the risk of behavioral problems in a child, according to results of a recent prospective study published in JAMA Pediatrics.

Investigators collected and analyzed data from the Avon Longitudinal Study of Parents and Children, a prospective cohort, from February 2015 to March 2016. They studied 7796 mothers who were enrolled in the study from 1991 to 1992 along with their children and partners. Use of acetaminophen was assessed by completing a survey at 18 and 32 weeks of pregnancy and then when the child was aged 61 months. Behavioral problems were maternally reported using the Strengths and Difficulties Questionnaire (SDQ) when the child was aged 7 years.

Prenatal acetaminophen use at 18 weeks (n = 4415; 53%) and 32 weeks of pregnancy (n = 3381; 42%) was tied to higher odds of having hyperactivity symptoms (risk ratio [RR], 1.31; 95% confidence interval [CI], 1.16-1.49) and conduct problems (RR, 1.42; 95% CI, 1.25-1.62). Acetaminophen use at 32 weeks was linked to higher odds of total difficulties (RR, 1.46; 95% CI, 1.21-1.77) and having emotional symptoms (RR, 1.29; 95% CI, 1.09-1.53). No association was found with maternal postnatal acetaminophen use (n = 6916; 89%) or partner acetaminophen use (n = 3454; 84%). Links between prenatal acetaminophen use and all SDQ domains were unchanged even after adjusting for postnatal use and partner use.

Next: Does low-level arsenic exposure affect fetal growth?

The researchers concluded that prenatal exposure to acetaminophen increases risk of many behavioral difficulties in children. The associations do not appear to be explainable through unmeasured behavioral or social factors. While the results could have practical implications, the researchers say that further study is needed to understand the mechanism and replicate their findings.