Ignite Creation Date:
2024-05-06 @ 1:42 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04091243
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2019-09-12
Brief Title:
Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users
Sponsor:
Tuen Mun Hospital
Organization:
Tuen Mun Hospital
Study Overview
Official Title:
Romosozumab Versus Denosumab for Osteoporosis in Long-term Glucocorticoid Users an Open Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glucocorticoid GC is the main stay of treatment of many rheumatic diseases but is also an important cause of secondary osteoporosis The long-term use of GCs increases the risk of fragility fracture at a much higher bone mineral density BMD than postmenopausal osteoporosis indicating an additional deleterious effect of GC on bone quality An increased relative risk of vertebral and hip fractures is demonstrated in chronic GC users with fracture risk proportional to the daily dose of GC Other studies have also confirmed that intermittent use of high-dose GC and the cumulative GC dose was associated with an augmented risk of osteoporotic fracture
Romosozumab ROMO is a humanized monoclonal antibody against sclerostin The landmark RCT has demonstrated efficacy of ROMO 210mg subcutaneously monthly over placebo in reducing vertebral fractures by 73 at 12 months in 7180 postmenopausal women with osteoporosis of the hip at entry Another RCT has demonstrated efficacy of ROMO in reducing vertebral and hip fractures in 4093 post-menopausal women at month 24
There are no data regarding the efficacy of ROMO in GC-induced osteoporosis Comparative study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet available in the literature This prompts the current pilot study to compare the efficacy of ROMO with denosumab in high-risk patients receiving long-term GCs
Romosozumab ROMO is a humanized monoclonal antibody against sclerostin The landmark RCT has demonstrated efficacy of ROMO 210mg subcutaneously monthly over placebo in reducing vertebral fractures by 73 at 12 months in 7180 postmenopausal women with osteoporosis of the hip at entry Another RCT has demonstrated efficacy of ROMO in reducing vertebral and hip fractures in 4093 post-menopausal women at month 24
There are no data regarding the efficacy of ROMO in GC-induced osteoporosis Comparative study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet available in the literature This prompts the current pilot study to compare the efficacy of ROMO with denosumab in high-risk patients receiving long-term GCs
Detailed Description:
Glucocorticoid GC is the main stay of treatment of many rheumatic diseases but is also an important cause of secondary osteoporosis The long-term use of GCs increases the risk of fragility fracture at a much higher bone mineral density BMD than postmenopausal osteoporosis indicating an additional deleterious effect of GC on bone quality More than one-third of postmenopausal women receiving GC therapy developed asymptomatic vertebral fractures A study in general practice reported an increased relative risk of vertebral and hip fractures in chronic GC users with fracture risk proportional to the daily dose of GC Another study also confirmed that intermittent use of high-dose GC and the cumulative GC dose was associated with an augmented risk of osteoporotic fracture
The glycoprotein sclerostin secreted by the osteocytes under the influence of mechanical loading inhibits activation of the canonical Wnt pathway involved in osteoblastogenesis and hence suppresses bone formation Moreover sclerostin enhances resorption of the bone by stimulating the production of RANKL by the osteocytes Romosozumab ROMO is a humanized monoclonal antibody against sclerostin The landmark RCT has demonstrated efficacy of ROMO 210mg subcutaneously monthly over placebo in reducing vertebral fractures by 73 at 12 months in 7180 postmenopausal women with osteoporosis of the hip at entry The suppression of markers of bone resorption and enhancement of markers of bone formation indicates that ROMO has a dual mode of action on the bones The efficacy of ROMO has also been tested against oral bisphosphonates A RCT was conducted in 4093 post-menopausal women who were assigned to receive either ROMO 201mg subcutaneously monthly or oral alendronate 70mg weekly for 12 months followed by open-label alendronate for another 12 months At month 24 a 48 lower risk of new vertebral fractures was observed in the ROMO 62 than the alendronate group 119 p0001 The risk of incident hip fractures was also significantly lower in the ROMO 2 than alendronate treated patients 32 p002 The frequencies of adverse events and serious adverse events however were similar in the two treatment arms
There are no data regarding the efficacy of ROMO in GC-induced osteoporosis Comparative study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet available in the literature This prompts the current pilot study to compare the efficacy of ROMO with denosumab in high-risk patients receiving long-term GCs
The glycoprotein sclerostin secreted by the osteocytes under the influence of mechanical loading inhibits activation of the canonical Wnt pathway involved in osteoblastogenesis and hence suppresses bone formation Moreover sclerostin enhances resorption of the bone by stimulating the production of RANKL by the osteocytes Romosozumab ROMO is a humanized monoclonal antibody against sclerostin The landmark RCT has demonstrated efficacy of ROMO 210mg subcutaneously monthly over placebo in reducing vertebral fractures by 73 at 12 months in 7180 postmenopausal women with osteoporosis of the hip at entry The suppression of markers of bone resorption and enhancement of markers of bone formation indicates that ROMO has a dual mode of action on the bones The efficacy of ROMO has also been tested against oral bisphosphonates A RCT was conducted in 4093 post-menopausal women who were assigned to receive either ROMO 201mg subcutaneously monthly or oral alendronate 70mg weekly for 12 months followed by open-label alendronate for another 12 months At month 24 a 48 lower risk of new vertebral fractures was observed in the ROMO 62 than the alendronate group 119 p0001 The risk of incident hip fractures was also significantly lower in the ROMO 2 than alendronate treated patients 32 p002 The frequencies of adverse events and serious adverse events however were similar in the two treatment arms
There are no data regarding the efficacy of ROMO in GC-induced osteoporosis Comparative study on the efficacy of ROMO and denosumab in post-menopausal osteoporosis is also not yet available in the literature This prompts the current pilot study to compare the efficacy of ROMO with denosumab in high-risk patients receiving long-term GCs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None