Incidence of osteonecrosis of the jaw in women with postmenopausal osteoporosis in the health outcomes and reduced incidence with zoledronic acid once yearly pivotal fracture trial.
BACKGROUND
The authors determined incidence of osteonecrosis of the jaw (ONJ) in a large, prospective three-year clinical trial of zoledronic acid in women with postmenopausal osteoporosis (PMO).


METHODS
A total of 7,714 women with PMO received intravenous zoledronic acid 5 mg or a placebo. No spontaneous reports of ONJ were received. An independent, blinded adjudication committee searched the trial's adverse event database by using 60 terms. On an ongoing basis, the committee reviewed the identified events, and it defined ONJ as exposed bone in the maxillofacial area with delayed healing for more than six weeks despite appropriate care.


RESULTS
One participant who received a placebo and one participant who received zoledronic acid experienced delayed healing associated with infection. Both conditions resolved after antibiotic therapy, débridement or both.


CONCLUSIONS
The occurrence of ONJ is rare in a PMO population, and delayed healing of lesions can occur with and without bisphosphonate use over three years.


CONCLUSIONS
The low incidence of ONJ must be assessed in the context of the clinical benefit of zoledronic acid therapy in reducing hip, vertebral and nonvertebral fractures in this at-risk population. There is no evidence to suggest that healthy patients with osteoporosis who are receiving bisphosphonates require any special treatment beyond routine dental care or to support altering standard treatment practices.
Grbic
John T
JT
Divisio of Oral Biology, Columbia University College of Dental Medicine, New York, NY 10032, USA. jtg2@columbia.edu
Landesberg
Regina
R
Lin
Shou-Qing
SQ
Mesenbrink
Peter
P
Reid
Ian R
IR
Leung
Ping-Chung
PC
Casas
Noemi
N
Recknor
Christopher P
CP
Hua
Ye
Y
Delmas
Pierre D
PD
Eriksen
Erik F
EF
D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects*; D004812:Epidemiologic Methods; D005260:Female; D006620:Hip Fractures / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects*; D007571:Jaw Diseases / Q000139:chemically induced / Q000453:epidemiology* / Q000628:therapy; D008875:Middle Aged; D010000:Osteitis / Q000628:therapy; D010019:Osteomyelitis / Q000188:drug therapy; D010020:Osteonecrosis / Q000139:chemically induced / Q000453:epidemiology* / Q000628:therapy; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010482:Periapical Abscess / Q000150:complications; D000077211:Zoledronic Acid
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid