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#Denosumab versus risedronate in glucocorticoid-induced #osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30075-5/fulltext
Between March 28, 2012, and June 30, 2015, 795 patients, 505 of whom were glucocorticoid continuing and 290 of whom were glucocorticoid initiating, were enrolled and randomly assigned (398 to denosumab, 397 to risedronate). Denosumab was both non-inferior and superior to risedronate at 12 months for effect on bone mineral density at the lumbar spine in both glucocorticoid-continuing (4·4% 95% CI 3·8–5·0 vs 2·3% 1·7–2·9; p<0·0001) and glucocorticoid-initiating (3·8% 3·1–4·5 vs 0·8% 0·2–1·5; p<0·0001) subpopulations. Incidence of adverse events, serious adverse events (including infections), and fractures was similar between treatment groups. The most common adverse events were back pain (17 4% patients in the risedronate group and 18 5% in the denosumab group) and arthralgia (21 5% patients in the risedronate group and 17 4% in the denosumab group). Serious infection occurred in 15 (4%) patients in the risedronate group and 17 (4%) patients in the denosumab group.
Interpretation
Denosumab could be a useful treatment option for patients newly initiating or continuing glucocorticoids who are at risk of fractures.
#Denosumab versus risedronate in glucocorticoid-induced #osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study
http://www.thelancet.com/journals/landia/article/PIIS2213-8587(18)30075-5/fulltext
Between March 28, 2012, and June 30, 2015, 795 patients, 505 of whom were glucocorticoid continuing and 290 of whom were glucocorticoid initiating, were enrolled and randomly assigned (398 to denosumab, 397 to risedronate). Denosumab was both non-inferior and superior to risedronate at 12 months for effect on bone mineral density at the lumbar spine in both glucocorticoid-continuing (4·4% 95% CI 3·8–5·0 vs 2·3% 1·7–2·9; p<0·0001) and glucocorticoid-initiating (3·8% 3·1–4·5 vs 0·8% 0·2–1·5; p<0·0001) subpopulations. Incidence of adverse events, serious adverse events (including infections), and fractures was similar between treatment groups. The most common adverse events were back pain (17 4% patients in the risedronate group and 18 5% in the denosumab group) and arthralgia (21 5% patients in the risedronate group and 17 4% in the denosumab group). Serious infection occurred in 15 (4%) patients in the risedronate group and 17 (4%) patients in the denosumab group.
Interpretation
Denosumab could be a useful treatment option for patients newly initiating or continuing glucocorticoids who are at risk of fractures.
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Effects of 24 Months of Treatment With #Romosozumab Followed by 12 Months of #Denosumab or Placebo in Postmenopausal Women With Low #Bone Mineral Density: A Randomized, Double‐Blind, Phase 2, Parallel Group Study
https://onlinelibrary.wiley.com/doi/abs/10.1002/jbmr.3452?af=R
Romosozumab markedly increased LS and TH BMD through month 24, with largest gains observed with romosozumab 210 mg QM (LS = 15.1%; TH = 5.4%). Women receiving romosozumab who transitioned to denosumab continued to accrue BMD, whereas BMD returned toward pretreatment levels with placebo. With romosozumab 210 mg QM, bone formation marker P1NP initially increased after treatment initiation and gradually decreased to below baseline by month 12, remaining below baseline through month 24; bone resorption marker β‐CTX rapidly decreased after treatment, remaining below baseline through month 24. Transition to denosumab further decreased both BTMs, whereas after transition to placebo, P1NP returned to baseline and β‐CTX increased above baseline. Adverse events were balanced between treatment groups through month 36. These data suggest that treatment effects of romosozumab are reversible upon discontinuation and further augmented by denosumab
Effects of 24 Months of Treatment With #Romosozumab Followed by 12 Months of #Denosumab or Placebo in Postmenopausal Women With Low #Bone Mineral Density: A Randomized, Double‐Blind, Phase 2, Parallel Group Study
https://onlinelibrary.wiley.com/doi/abs/10.1002/jbmr.3452?af=R
Romosozumab markedly increased LS and TH BMD through month 24, with largest gains observed with romosozumab 210 mg QM (LS = 15.1%; TH = 5.4%). Women receiving romosozumab who transitioned to denosumab continued to accrue BMD, whereas BMD returned toward pretreatment levels with placebo. With romosozumab 210 mg QM, bone formation marker P1NP initially increased after treatment initiation and gradually decreased to below baseline by month 12, remaining below baseline through month 24; bone resorption marker β‐CTX rapidly decreased after treatment, remaining below baseline through month 24. Transition to denosumab further decreased both BTMs, whereas after transition to placebo, P1NP returned to baseline and β‐CTX increased above baseline. Adverse events were balanced between treatment groups through month 36. These data suggest that treatment effects of romosozumab are reversible upon discontinuation and further augmented by denosumab
Effect of #denosumab on osteolytic lesion activity after total #hip arthroplasty: a single-centre, randomised, double-blind, placebo-controlled, proof of concept trial
https://2medical.news/2021/01/21/effect-of-denosumab-on-osteolytic-lesion-activity-after-total-hip-arthroplasty-a-single-centre-randomised-double-blind-placebo-controlled-proof-of-concept-trial/
Osteolysis causes recurrent pain and disability after total hip arthroplasty. We investigated the effect of the human monoclonal antibody denosumab on osteolytic lesion activity in patients undergoing revision total hip arthroplasty surgery to show the biological proof of concept for a non-surgical treatment for the disease.. Findings Between Dec 12, 2012, and June 24, 2018, 51 patients were assessed for eligibility, of whom 24 were …
https://2medical.news/2021/01/21/effect-of-denosumab-on-osteolytic-lesion-activity-after-total-hip-arthroplasty-a-single-centre-randomised-double-blind-placebo-controlled-proof-of-concept-trial/
Osteolysis causes recurrent pain and disability after total hip arthroplasty. We investigated the effect of the human monoclonal antibody denosumab on osteolytic lesion activity in patients undergoing revision total hip arthroplasty surgery to show the biological proof of concept for a non-surgical treatment for the disease.. Findings Between Dec 12, 2012, and June 24, 2018, 51 patients were assessed for eligibility, of whom 24 were …