Vitamin D3 supplementation is not associated with a reduced risk for fractures among healthy middle-aged and older adults, according to study results published in The New England Journal of Medicine.
“Our results do not support the use of vitamin D supplements to prevent fractures in generally healthy U.S. men and women,” Meryl Susan LeBoff, MD, chief of the calcium and bone section in the endocrinology, diabetes and hypertension division at Brigham and Women’s Hospital, and professor of medicine at Harvard Medical School, told Healio. “These results do not apply to older adults in residential communities or those with severe vitamin D deficiency, low bone mass or osteoporosis.”
LeBoff and colleagues conducted an ancillary study of the VITAL trial, a randomized controlled trial analyzing whether supplemental vitamin D3 could reduce the risks for cancer and cardiovascular disease for men aged 50 years and older and women aged 55 years and older. The ancillary study followed 25,871 VITAL participants (mean age, 67.1 years; 50.6% women; 20.2% Black) for a median of 5.3 years to determine whether supplemental vitamin D reduced the risk for fractures compared with placebo.
Fractures were initially self-reported in annual questionnaires. After a fracture was reported, participants were sent an authorization form to obtain medical records and a fracture questionnaire to obtain fracture date, location, any association with cancer or prosthesis, and fracture circumstances. Medical record requests were sent to health care professionals to obtain radiologic reports and images, orthopedic notes, and operative or procedure records. All incident fractures were adjudicated by investigators and study staff. All fractures were included in the study, regardless of trauma.
Of those who reported a fracture, 87% consented to a medical record review, and documentation was obtained for 91.3% of those who consented. There were 1,991 fractures confirmed in 1,551 participants.
Researchers observed no difference in risks for incident total fractures, nonvertebral fractures or hip fractures between the vitamin D and placebo groups. Baseline age, sex, race, BMI, personal use of supplemental calcium or vitamin D, and baseline 25-hydroxyvitamin D levels did not affect the associations. Vitamin D supplementation also did not affect the risk for fractures among those who used osteoporosis medication or adults with a history of fragility fractures.
There were no associations observed in sensitivity analyses. In secondary analysis when toe, finger, skull, periprosthetic and pathologic fractures were excluded, there was still no difference in fracture risk between the vitamin D and placebo groups. No difference in risk was observed for major osteoporotic fractures, pelvic fractures or wrist fractures excluding periprosthetic and pathologic fractures.
The researchers noted that vitamin D was not associated with a reduced risk for fractures, but there was a slight benefit observed in VITAL on spine and total hip bone mineral density among adults with baseline free 25-(OH)D levels below the median.
“Ongoing studies are focusing on whether free vitamin D levels or genetic variation in vitamin D absorption, metabolism or receptor function will provide information about individuals who may benefit from supplemental vitamin D on musculoskeletal health,” LeBoff said.
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Meryl Susan LeBoff, MD, can be reached at email@example.com.