- With denosumab (e.g., Prolia) therapy for postmenopausal osteoporosis, osteonecrosis of the jaw (ONJ) is quite rare at 5.2 cases for every 10,000 patient-years.
- Of 11 cases with known outcomes, all healed.
Why this matters
- Aging also involves more dental implants, tooth loss and extraction, and jaw surgery.
- There are concerns that antiresorptive agents like denosumab might seriously increase ONJ risk.
- 45.1% of participants had ≥1 oral procedure/event.
- Procedure rates were quite similar for continuous denosumab and placebo-to-denosumab groups.
- Overall ONJ rate was 5.2/10,000 person-years.
- 12 cases total (all self-report):
- 10 resolved with treatment.
- 1 is still in treatment but healing.
- 1 is unknown, consent withdrawn.
- Most ONJ followed extractions or bad denture fit.
- Only 1 ONJ case among 212 patients with dental implants; patient continued denosumab, ONJ healed, implant is still in place.
- 7-year extension of randomized, double-blind, placebo-controlled, multinational 3-year FREEDOM trial .
- 4550 participants from original trial of denosumab (60 mg SQ every 6 months) vs placebo.
- All continued on denosumab (original treatment group) or started on denosumab (original placebo group) at beginning of 7-year extension period.
- 3591/4550 completed the oral events survey.
- Outcome: rates or oral procedures/events, ONJ.
- Funding: Amgen, Inc.
- Self-reported dental information.