The Joint Annual Scientific Meetings of the Endocrine Society of Australia and the Society for Reproductive Biology 2018

Teriparatide improves healing of medication-related osteonecrosis of the jaw: a placebo-controlled, randomized trial (#121)

Ie-Wen Sim 1 2 3 , Gelsomina L Borromeo 4 , John F Seymour 5 , Peter R Ebeling 2
  1. Melbourne Medical School, University of Melbounre, Melbourne, Victoria, Australia
  2. Department of Medicine, Monash University, Melbourne, Victoria, Australia
  3. Eastern Health, Monash Health, Western Health, Melbourne, Victoria, Australia
  4. Eastern Health Clinical School, Monash University, Melbourne, Victoria, Australia
  5. Department of Haematology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Medication-related osteonecrosis of the jaw (MRONJ) is an infrequent, but potentially debilitating, condition associated with antiresorptive therapy. Whereas MRONJ incidence can be reduced by optimising oral health, management of established cases remains challenging.

We conducted a prospective double-blind, placebo-controlled, randomised trial investigating the efficacy of 8 weeks teriparatide (20μg/day) treatment in 34 participants, with a total of 47 MRONJ lesions. Ten participants had multiple lesions. Most participants had at least moderate severity MRONJ, with 61.8% being stage 2 or 3, ie exposed bone associated with infection and/or complications such as fistulae or fracture. Participants were followed up for 12 months, with primary outcomes including the clinical and radiological resolution of MRONJ lesions. The Oral Health Impact Profile-14 (OHIP-14) questionnaire was used to assess quality of life. Baseline characteristics were similar between groups, with the mean time from MRONJ diagnosis being 12 months. Antiresorptive therapy was indicated for treatment of skeletal-related events in the setting of malignancy in the majority of participants (79.4%).

In the teriparatide arm, P1NP increased by 47% (p < 0.001) and fluoride-PET tracer uptake increased by 24% (p = 0.008). 10 of 22 (45.4%) MRONJ lesions in the teriparatide group resolved by 52 weeks compared with 8 of 24 (33.3%) lesions in the placebo group, with a greater rate of resolution of MRONJ sites with teriparatide (OR = 0.15 vs OR 0.40, p = 0.013). Bone mineral density and OHIP-14 scores were similar between groups. The incidence of adverse events was low and balanced between groups. Adverse events were mild in severity, including nausea, anorexia and musculoskeletal pain.

Therefore, teriparatide improves the rate of resolution of established MRONJ lesions, and represents an efficacious and safe treatment for MRONJ.