For denosumab-treated women with postmenopausal osteoporosis, invasive oral procedures and events, including dental implants, tooth extraction, natural tooth loss, scaling/root planning, and jaw surgery, are common and associated with osteonecrosis of the jaw.
In the Biologics License Application (BLA) resubmission, Amgen and UCB proposed to narrow the indication to treatment of osteoporosis in postmenopausal women at high risk of fracture.
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) was a multicenter, international, randomized, double-blind, alendronate-controlled study (n=4,093) in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.
The data showed a statistically significant fracture risk reduction through 3.5 years.
Sanga, Panna MD et al. “Long-Term Safety and Efficacy of Fulranumab in Patients With Moderate-to-Severe Osteoarthritis Pain: A Phase II Randomized, Double-Blind, Placebo-Controlled Extension Study”
The International Osteoporosis Foundation and European Calcified Tissue Society Working Group proposed a screening strategy measuring certain bone turnover markers in patients who have initiated oral bisphosphonate therapy for postmenopausal osteoporosis as a practical way to identify low adherence.
Denosumab injections prevent osteoporosis in patients with primary biliary cholangitis and autoimmune hepatitis, with few adverse effects.
