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FREEDOM extension: Denosumab continued to improve BMD, prevent fractures
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BALTIMORE — The initial reports from the extension of the FREEDOM trial show continued efficacy of denosumab for increasing bone mineral density and prevention of fracture in patients receiving the drug in the long term and those switched over from placebo treatment.
“Denosumab treatment for up to 8 years was associated with persistent reduction of bone turnover … continued increase in bone mineral density … and low, new vertebral, non-vertebral and hip fracture incidence,” Socrates Papapoulos, MD, of the Leiden University Medical Center, the Netherlands, said in his presentation here at ASBMR 2013. “It’s the same picture in crossover and long-term patients. The overall benefit/risk profile of denosumab appears favorable up to 8 years of continuous treatment.”
The extended FREEDOM results looked at 1,382 long-term patients and 1,298 crossover patients who had completed dosing in year 8.
Papapoulos showed that the long-term group — those treated with denosumab (Prolia, Amgen) from the start of the study — had an 18.4% improvement in lumbar spine BMD after 8 years, and those patients who switched from placebo to denosumab (the crossover group) showed a 13.7% increase. Similarly, hip BMD increased 8.3% and 4.8% in the long-term and crossover treatment groups, respectively.
“It shows the consistency of the effect of denosumab on bone mineral density within the study but also among studies because I have to remind you that similar increases in bone mineral density were seen in the phase 2 study with denosumab,” Papapoulos said.
Additionally, results showed a stable rate of vertebral fracture in the long-term treatment group and an immediate drop in fractures in the crossover group. Both were maintained for the 8 years of study, he said.
It appeared that in the fourth year of treatment, there was a further reduction in the incidence of non-vertebral fractures, Papapoulos said.
“When we look now in the crossover group, we see exactly the same picture,” he said. “These appear to be a repeated phenomenon.”
There was no evidence of accumulation of adverse events (ie, infection and malignancies) with time. – by Katrina Altersitz
For more information:
Papapoulos S. Abstract LB-MO26. Presented at: the American Society of Bone and Mineral Research 2013 Annual Meeting; Oct. 4-7, 2013; Baltimore.
Disclosure: Papapoulos reports relationships with Amgen, Axsome Therapeutics, GlaxoSmithKline, Merck & Co. and Novartis.