Cincinnati, OH—Women prescribed therapy for postmenopausal osteoporosis are sometimes hesitant to take the medications because of fear of side effects. Based on a new study, pharmacists can provide them with some reassurance.

A study in the Journal of Clinical Endocrinology & Metabolism determined that oral complications are actually rare in women taking medications for postmenopausal osteoporosis. The findings refer to osteonecrosis of the jaw (ONJ), defined as exposed bone in the jaw that takes 8 weeks or longer to heal, despite effective treatment, which occurs most often after a major dental procedure.

The side effect was first reported in 2003 in patients with advanced cancer receiving high doses of zoledronic acid and denosumab, which also is used to treat osteoporosis.

The study noted that while rates in cancer patients receiving high doses are around 1% to 2% a year, ONJ is considerably less common in patients with osteoporosis receiving lower doses—about one case every 10,000 patient-years.

“Our study covered the seven-year extension of the denosumab pivotal trial. We found dental procedures were common among these patients, but ONJ was rare with only 5.2 cases for every 10,000 patient-years. Not only was ONJ rare, but the 11 cases where the outcome is known have healed,” explained lead author, Nelson Watts, MD, of Mercy Health in Cincinnati, Ohio. “The ONJ cases typically followed dental extractions or poorly fitting dentures. Of the 212 patients with dental implants, only one developed ONJ, and she continued denosumab, healed her ONJ, and still has the implant.”

Used for the analysis was the randomized, double-blind, placebo-controlled 3-year trial (FREEDOM) followed by 7 years of open-label denosumab (FREEDOM Extension).

Participants received SC denosumab 60 mg or placebo Q6M for 3 years, then 7 years of open-label denosumab.

At Extension Year 3, women were asked to record their history of invasive oral procedures and events (OPEs), such as dental implants, tooth extraction, natural tooth loss, scaling/root planing, or jaw surgery, since the start of the Extension to Year 2.5, as well as oral events in the prior 6 months. The questionnaire was then administered every 6 months (Q6M) until the end of the Extension.

Results indicated that 45.1% of respondents reported at least one invasive OPE; overall, the exposure-adjusted ONJ rate in the FREEDOM Extension was 5.2 per 10,000 subject-years. Researches emphasize that ONJ incidence was higher in those reporting an OPE (0.68%) than not (0.05%).

“While invasive OPEs were common in these denosumab-treated women and were associated with an increased ONJ incidence, the overall rate of ONJ was low, and all cases with complete follow-up resolved with treatment,” study authors concluded.

“My hope is our study will help patients and oral care providers be better informed about the low risk of ONJ compared to the fracture prevention benefits of antiresorptive therapy in women with postmenopausal osteoporosis,” Watts said.

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