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Osteoporosis is the most common indication for antiresorptive drugs (ARDs). Medication-related osteonecrosis of the jaw (MRONJ) is a severe complication of ARDs. Multiple risk factors can increase the risk of MRONJ, one of which is the duration of ARD intake, which is usually prolonged for osteoporosis cases. Prevention of MRONJ relies on collaborative care between treating physicians and dental practitioners. Therefore, knowledge about MRONJ and its prevention strategies is crucial for both teams.
UNASSIGNED: This study aimed to assess the knowledge and attitudes of physicians toward MRONJ in osteoporosis patients. Another aim was to develop recommendations for the prevention of MRONJ.
UNASSIGNED: Through an online survey, basic information such as the practice location, training, knowledge, perceptions, and attitudes of physicians regarding ARDs and MRONJ in osteoporosis patients was collected. Statistical analysis was performed for all variables, and their correlations were explored.
UNASSIGNED: A total of 221 physicians participated in the survey: 34.8% were rheumatologists, 25.3% were endocrinologists, 8.6% were family medicine physicians, 5.9% were orthopedists, and 5.9% were internal medicine physicians. Of them, 58.0% reported more than 6 years of experience. Only 78.7% were aware of MRONJ and recognized that bisphosphonates (BPs) can contribute to MRONJ. In contrast, 56.0% recognized denosumab as a causative factor for MRONJ. Duration of ARD therapy and pre- and post-ARD dental care were known to influence the risk of MRONJ by 62% and 65.6% of the participants, respectively. Only 41.6% and 31.2% of participants informed patients about MRONJ prior to BP and denosumab therapy, respectively. Only 25.3% and 20.8% referred patients to dentists before BP and denosumab therapy, respectively. Overall, 65.6% of the participants had a negative attitude toward MRONJ, and 34.4% had a positive attitude. A positive attitude was mostly observed among rheumatologists (55.8%) compared to other specialists (p <0.001). More years of experience were associated with a higher level of knowledge and positive attitude.
UNASSIGNED: The findings of this study identified a notable gap in the awareness, knowledge and attitudes of physicians regarding MRONJ in osteoporosis patients. Continuing education programs about ARDs and MRONJ risk are highly recommended.

A case report of bilateral atypical femur fractures (AFF) in a bisphosphonate naive patient. A 62-year-old female bisphosphonate naive patient was started on denosumab for osteoporosis. Approximately 3 years later she complained of right hip pain and was found to have a bilateral incomplete AFFs. She was asymptomatic on the left lower limb. Patient was managed conservatively and placed on protected weight bearing on both legs. Symptoms subsequently resolved over a period of 3 months, although radiographic findings remained at approximately 1 year. AFFs may be associated with patients on denosumab therapy even without a prior history of bisphosphonate use. Patients should be counselled appropriately and monitored for such complications.

On June 23, 2020, Prolia® (denosumab) was approved by the National Medical Products Administration (NMPA) in the People\'s Republic of China as the first monoclonal antibody for the treatment of postmenopausal women with osteoporosis at high risk of fractures. Its brand name in Chinese is , a transliteration from the English name \"Prolia\", which has an implied meaning of \"to give strength to everyone\"- a suitable name for a potent anti-resorptive therapy. The approval was supported by a novel marketing authorization application (MAA) that included data from Prolia\'s global clinical trial program establishing favorable efficacy and safety, augmented by results from a real-world evidence (RWE) study confirming the effectiveness and safety of Prolia in clinical practice within Taiwan and Hong Kong. Key constructs for this registration-quality RWE study included the fit-for-purpose assessment of data quality, methodology and quantitative assessment of potential biases, good practices of study conduct, and reproducibility of results. Using data from clinical practice in Taiwan and Hong Kong to evaluate the benefits versus risks of Prolia treatment in ethnic Chinese women with postmenopausal osteoporosis, the RWE study results for effectiveness were comparable to efficacy demonstrated in the global clinical trial program and results for safety were consistent with the incidence observed in global post-marketing safety studies. While RWE is often used to monitor postmarket safety of drug products, support health insurance coverage decisions, and inform clinicians on real-world use of medicines, it has not been widely used to support regulatory approval for new medicines in lieu of clinical bridging studies in countries where such studies are required. Well-conducted registrational RWE studies can play a pivotal role in complementing the totality of evidence presented in an MAA. The benefits of such an approach include avoiding the collection of additional placebo-controlled trial data in populations where adequate ethnic characterization of efficacy, effectiveness, and safety may already exist from postmarketing sources, and accelerate access for patients to innovative medicines in important regions. Here, we describe a regulatory case study of a novel MAA incorporating RWE that provided important evidence to confirm the benefit:risk of a new drug and facilitated a label expansion to a new patient population.

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This is the first report describing three ipsilateral femoral stress fractures in a patient taking denosumab.
BACKGROUND: Multiple reports of atypical femur fractures (AFF) in patients receiving denosumab have emerged recently. Denosumab is an anti-resorptive agent approved for treatment of osteoporosis. It is a human monoclonal antibody which blocks osteoclast activation, maturation, and function.
METHODS: This is a case report of a 74-year-old female patient who sustained three stress fractures of her left femur.
RESULTS: The patient healed her fractures after intramedullary nailing of the femur and was able to return to her activities.
CONCLUSIONS: High index of suspicion is needed in any patient with osteoporosis on denosumab complaining of thigh or groin pain. Careful examination and radiographic studies of both femurs are warranted if AFF is discovered.

Denosumab is a fully human monoclonal antibody which is used to treat osteoporosis and has been shown to cause hypocalcemia in patients with underlying prostatic and bone malignancies, renal impairment, postmenopausal state, and/or vitamin D deficiency. We present a case of a male patient, with a past medical history negative for the aforementioned conditions, who presented with right shoulder pain and was found to be severely hypocalcemic secondary to denosumab.