More than 10 million US adults have osteoporosis, and 80 percent of US osteoporosis patients are female, according to the Endocrine Society’s Endocrine Facts and Figures at endocrinefacts.org. Researchers working on issues of bone health presented the results of their findings during Sunday’s press conference, offering possible solutions to the growing problem.
An industry-sponsored study found that the investigational drug abaloparatide-SC may help increase bone mineral density (BMD) in postmenopausal women with osteoporosis and reduce their risk of vertebral and nonvertebral fractures.
Paul Miller, MD, FACP, described the randomized, double-blind, comparative multicenter international phase 3 ACTIVE trial that evaluated the efficacy and safety of 80 micrograms of abaloparatide-SC in preventing fractures in otherwise healthy, ambulatory, postmenopausal women with osteoporosis.
At 18 months, abaloparatide-SC significantly increased BMD from baseline at the lumbar spine by 9.2 percent, total hip by 3.4 percent and the femoral neck by 2.9 percent, compared to placebo. The investigational drug also reduced new vertebral fractures by 86 percent, nonvertebral fractures by 43 percent, clinical fractures by 43 percent, and major osteoporotic fractures by 70 percent, compared with placebo, according to Dr. Miller. Results were also favorable to another drug tested in the trial, teriparatide.
Abaloparatide-SC has recently been submitted to the FDA for approval as a treatment for osteoporosis.
Another study looked at the association between the use of stimulant drugs to treat attention deficit hyperactivity disorder (ADHD) and low bone density.
Researchers at Weill Cornell Medicine in New York used data from the National Health and Nutrition Examination Survey and found that among stimulant users, the average bone mineral content at the lumbar spine was 5.1 percent lower than non-users and 5.3 percent lower at the hip, said lead investigator Alexis Feuer, MD. Bone density was 3.9 percent lower in stimulant users at the spine and 3.7 lower at the hip, she added.
Dr. Feuer said that while the study does not prove stimulant medicine is the cause of the lower bone density, prospective research studies are needed to evaluate the effects of stimulant medicine on the skeleton of growing children.
She said the study suggests pediatricians should monitor bone health of their ADHD patients on stimulant medicines by ensuring they maintain healthy body weight, are engaging in weight bearing exercise, and have adequate intake of calcium and vitamin D.
The final study looked at the effects of antidepressant use with selective serotonin reuptake inhibitors (SSRIs) during pregnancy and breast-feeding on future bone health. Researchers found the use of SSRIs causes decreased bone density in mothers that may put them at higher risk of broken bones later in life.
Laura Hernandez, PhD, said researchers gave fluoxetine to six mice during pregnancy and lactation and compared them to six mice that received saline. Six additional mice also received folic acid with fluoxetine and six received folic acid with saline. The fluoxetine recipients had a lower expression of the bone-building protein osteocalcin at the femur than the saline groups. The fluoxetine groups also demonstrated increased expression in the femur of macrophage colony-stimulating factor.
High-dose folic acid tended to reverse the effects of SSRI on bone, researchers found.