In January, the U.S. Food & Drug Administration approved indomethacin in an oral suspension, a generic version of Indocin Oral Suspension. The agency also issued a boxed warning and updated label for denosumab, warning of the risks of severe hypocalcemia in patients with chronic kidney disease.
During ACR Convergence 2023, experts discussed developments in the treatment and diagnosis of osteoporosis, addressing risks of treatment discontinuation, the use of bone turnover markers in patient assessment and vitamin D.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, such as hospitalization and death, in patients on dialysis taking denosumab.
Using three complicated patient cases, Kenneth G. Saag, MD, MSc, shared his expertise on osteoporosis and walked through his thought process and the literature, during a session of the 2022 ACR Education Exchange.
In a small study of men with low bone mineral density (BDM) living with HIV and taking anti-retroviral therapy, both zoledronate or denosumab were well tolerated and effective for bone mineral density of the lumbar spine and femoral neck.
Treatment with denosumab for patients with RA and glucocorticoid-induced osteoporosis led to greater increases in bone mineral density of the lumbar spine and hips of patients than treatment with risedronate.
As the U.S. and other patents for branded denosumab products get closer to expiring, drug manufacturers are initiating clinical trials for more affordable, biosimilar versions of the treatment.
Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.