The participants were randomly assigned a 1:1 ratio to receive 8 weeks of once-daily SC injections of either of parathyroid hormone analogue, teriparatide (20 µg/day; 19 patients) or saline (15 patients), with all patients receiving supplementation with oral calcium carbonate and vitamin D as well as standard clinical care for MRONJ. The primary study outcome was resolution of MRONJ as measured by oral examination and CBCT imaging. The study participants were followed for 12 months, and oral examinations were conducted at 0, 4, 8, 12, 24, 36, and 52 weeks. The secondary outcomes measured included quality of life using the Oral Health Impact 14 questionnaire, evaluation of bone mineral density at 0 and 52 weeks, and measurements of circulating markers of bone turnover, including procollagen type 1.
The researchers reported that teriparatide was associated with a greater rate of resolution of MRONJ lesions (odds ratio [OR], 0.15 vs. 0.40; P = .013), and 45.4% of lesions resolved by 52 weeks compared with 33.3% in the placebo group. Teriparatide was also linked with decreased bony defects at week 52 (OR, 8.1; P = .017). In addition, a greater percentage of patients receiving teriparatide (80.0%) demonstrated heightened bone volume and a reduction in the size of bony defects at 12 months compared with those receiving saline injections (31.3%; OR, 8.1; 95% CI, 1.36-66.20; P = .017).
The incidence of adverse events was mostly mild and was balanced between groups, including nausea, anorexia, and musculoskeletal pain. The study concluded that 8 weeks of daily SC injection of teriparatide was linked with an augmented rate of resolution of medication-related osteonecrosis of the jaw. Additionally, this short-term therapy was not associated with any safety concerns, and the researchers indicated that there were only a few reports of severe adverse events and no cases of new malignancy or worsening of preexisting malignancy.
In the conclusion of the study, the authors noted that, “Notwithstanding that most participants previously received high doses of potent antiresorptive therapies, teriparatide was able to elicit an osteoblastic response as demonstrated both biochemically and radiologically.” The authors also revealed that to their knowledge, their data represents the first and only randomized, placebo-controlled trial to demonstrate therapeutic efficacy in MRONJ and support the use of teriparatide as a treatment of established MRONJ.
Sim et al also noted that the main strength of their trial is that it is the only placebo-controlled clinical trial investigating treatment of established MRONJ. Moreover, the authors also noted that all phases of trial design and its conduct were investigator-driven, and the efficacy was validated by a variety of supportive translational mechanistic studies. They concluded that their data demonstrated that 8 weeks of once-daily use of teriparatide enhances the resolution of established MRONJ lesions and therefore represents a safe and valuable therapy for MRONJ.
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