Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-09
Brief Title:
Romosozumab Versus Denosumab in GIOP a 2-year Extension Study
Sponsor:
Tuen Mun Hospital
Organization:
Tuen Mun Hospital
Study Overview
Official Title:
Romosozumab Versus Denosumab in Patients With Glucocorticoid-induced Osteoporosis a 2-year Extension Study of a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The investigators conducted an open-label randomized controlled trial RCT in chronic glucocorticoid GC users with moderatehigh risk of fracture to compare the efficacy and tolerability of romosozumab ROMO for 12 months followed by denosumab DEN for 12 more months vs DEN for 24 months throughout Superiority of ROMODEN to DENDEN in raising the spine bone mineral density BMD was demonstrated at month 12 and month 24 The present study was to report the further BMD changes at 48 months 2 year extension for those participants who were maintained on DEN treatment
Detailed Description:
The investigators conducted a pilot open-label 24-month randomized controlled trial RCT comparing the efficacy of romosozumab ROMO with denosumab DEN in moderatehigh risk adult patients using long-term GCs defined as a daily prednisolone dose of 5mgday for 12 months All patients had moderate to high risk of osteoporotic fracture as evidenced by at least one of the following 1 a personal history of fragilityvertebral fracture 2 dual energy X-ray absorptiometry DXA T score -25 age 40 years or Z scores -30 age 40 years at spine hip or femoral neck or 3 high risk of 10-year FRAX-estimated major fracture
Of the 70 patients enrolled 63 completed the study At month 12 the spine bone mineral density BMD increased significantly in both the ROMO and DEN groups The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients p0001 Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups the BMD gain was not significantly different between the groups At month 24 the spine BMD continued to increase in both the ROMO and DEN groups and the BMD gain remained significantly greater in ROMO-treated patients
As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48
Of the 70 patients enrolled 63 completed the study At month 12 the spine bone mineral density BMD increased significantly in both the ROMO and DEN groups The spine BMD gain from month 0-12 was significantly greater in ROMO-treated patients p0001 Although the hip BMD at month 12 also increased significantly in the ROMO and DEN groups the BMD gain was not significantly different between the groups At month 24 the spine BMD continued to increase in both the ROMO and DEN groups and the BMD gain remained significantly greater in ROMO-treated patients
As there are no long-term data on the sequential use of ROMO and DEN in patients with GIOP the current 2-year extension study is planned to observe the BMD changes at the spine and the hip of patients in the two treatment groups at month 48
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?:
None
Is an FDA AA801 Violation?:
None