Nutraceuticals: Calcium & Vitamin D

Indication: Bone Mineral Density

Source: Epilepsia, 54(11):1997–2004, 2013

Research: Antiepileptic drug and osteoporosis prevention trial (ADOPT) was designed as a prospective 2-year double-blind, randomized placebo-controlled study involving 80 male veterans with epilepsy who were being treated with antiepileptic drugs (AEDs) such as phenytoin, phenobarbital, sodium valproate, or carbamazepine for a minimum of 2 years. All enrolled participants received calcium and vitamin D supplementation, and were randomized to risedronate or matching placebo. Total body, bilateral proximal femora and anteroposterior (AP) lumbar spine BMDs in addition to morphometric lateral vertebral assessments (LVAs) were evaluated by a dual energy x-ray absorptiometry (DXA) instrument. Comparisons of BMDs were made between baseline, 1 year and after 2 years of enrollment in the study. The incidence of new vertebral and nonvertebral fractures was the secondary end point.
Results: Of the 80 patients initially enrolled, 53 completed the study. At the end of the study, in the placebo plus calcium and vitamin D group, researchers observed a significant improvement in BMD at any of the evaluated sites when compared to their baseline scans in 69% (18/26). In the risedronate plus calcium and vitamin D group, researchers observed significant improvement of BMDs in 70% (19/27) of the participants. At the end of the study, the risedronate group experienced a significant increase of BMD at the lumbar spine, which was significantly larger than that seen in the placebo group. There were non-significant differences between the groups regarding changes of total body BMD or at the proximal bilateral femora.

Calcium and vitamin D together or in addition to risedronate improved BMD in more than 69% of male veterans with epilepsy who were taking AEDs. In the group receiving risedronate plus calcium and vitamin D there was a significant improvement of BMD at the lumbar spine as compared to the placebo group. The use of risedronate plus calcium and vitamin D prevented the incidence of new vertebral fractures and one nonvertebral fracture in this cohort.