Zanchetta MB, et al. - A post FREEDOM study is carried out to assess changes in bone mineral density (BMD) after a year of discontinuation of Denosumab (DMAb) in a group of postmenopausal women treated with DMAb for 7 or 10 years. And also aimed to assess the occurrence of fragility fractures. These outcomes depict the rapid bone loss occurring after cessation of denosumab treatment. Further studies are needed to evaluate if patients have a higher risk of fracture after stopping DMAb and if so, which patients have the highest risk, and evaluate the role of transitioning to bisphosphonates in the long term.

Methods

• To take part in this follow-up study, they invited women who had participated in the FREEDOM study and its extension.
• BMD at LS and hip and spine X-rays were obtained.
• Results were compared to the last value obtained while in treatment to evaluate changes after discontinuation.

Results

• In this study, they observed that 38 women, mean age: 81 ± 3.4 years completed study procedures; none had received bisphosphonates after stopping DMAb.
• 17 months (range 16-20 months) was the mean gap time between DMAb last dose and the follow-up visit.
• Bone mineral density (BMD) decreased significantly in all regions: - 8.1% in LS, - 6% in FN, and - 8.4% in TH.
• Five (5/38, 13.15%) patients had a fragility fracture, one suffered a wrist fracture, and four experienced vertebral fractures.
• Three patients suffered one vertebral fracture and one of them had two vertebral fractures.
• Laboratory outcomes demonstrated the following mean values: CTX = 996 ± 307 pg/ml (normal values 550 ± 226 pg/ml); osteocalcin = 55.2 ± 18.6 ng/ml (normal value 42 ng/ml); and 25 OH vitamin D = 23.7 ± 6.9 ng/ml.