Ignite Creation Date:
2024-05-06 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01770106
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2013-01-03
Brief Title:
RA Denosumab on Bone Microstructure Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Comparison of the Effect of Denosumab and Alendronate on Bone Density and Microarchitecture in Rheumatoid Arthritis Females With Low Bone Mass A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-09
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:
The aim of this study is to compare the effects of denosumab and a current standard treatment on cortical and trabecular microarchitecture at the radius and second metacarpal in rheumatoid arthritis RA patients with low bone mineral density using high resolution peripheral quantitative computed tomography HR-pQCT during a 6-month open-label randomized controlled study Forty ambulatory Chinese females who consent to receive alendronate as standard treatment subjective to the randomization will be enrolled in this study Subjects will be randomized to 2 arms receiving 1 subcutaneous injection of denosumab 60mg Prolia every 6 months n20 or 2 oral alendronate weekly Fosamax once weekly 70 mg n20 In addition all patients will be given a daily calcium supplement 1500mg caltrate day and 1 multivitamin tablet per day Efficacy and safety assessment will be performed at baseline month 3 and month 6 aBMD of lumbar spine total hip and non-dominant distal radius will be measured using dual-energy X-ray absorptiometry DXA and microarchitecture of bone is measured at the non-dominant distal radius and the second metacarpal bone of the non-dominant hand using HR-pQCT
Detailed Description:
Rheumatoid arthritis RA is a chronic systemic inflammatory disease most typical in women Generalized osteoporosis is common in RA at axial and appendicular skeleton and in females and males Denosumab is a fully humanized IgG monoclonal antibody that targets the receptor activator of nuclear factor κB ligand RANKL Denosumab prevents the binding and activation of the RANK receptors on the osteoclasts and hence inhibits osteoclasts formation activation function and survival Denosumab results in more rapid and greater reductions in bone remodeling and correspondingly greater increases in areal bone mineral density aBMD at all skeletal sites Denosumab was approved by FDA in June 2010 for the treatment of postmenopausal women with osteoporosis at high risk of fracture Denosumab Prolia is also licensed in Hong Kong
A high-resolution peripheral quantitative computed tomography HR-pQCT capable of achieving an isotropic voxel size of 80μm at tolerable radiation doses 3μSv is available for the assessment of trabecular and cortical microarchitecture at the distal radius and tibia This technique bears excellent precision for both density and microstructure measures Denosumabs greater potency in suppressing bone remodeling and greater effect on areal BMD than alendronate particularly at predominantly cortical sites such as the distal third of the radius may reflect the differing mechanism of action of these drugs which in turn influence bone microarchitecture
The aim of this study is to compare the effects of denosumab and a current standard treatment on cortical and trabecular microarchitecture at the radius and second metacarpal in RA patients with low bone mineral density using HR-pQCT during a 6-month open-label randomized controlled study One bisphosphonate namely alendronate sodium or alendronate is chosen to generate a heterogeneous and comparable active control group This is a 6-month open-label randomized controlled clinical trial Forty ambulatory Chinese females who consent to receive alendronate as standard treatment subjective to the randomization will be enrolled from the rheumatology clinic of the Prince of Wales Hospital in this study Subjects will be randomized to 2 groups receiving 1 subcutaneous injection of denosumab 60mg Prolia every 6 months n20 or 2 a standard treatment oral alendronate weekly Fosamax once weekly 70 mg n20 In addition all patients will be given a daily calcium supplement 1500mg caltrate day and 1 multivitamin tablet per day Efficacy and safety assessment will be performed at baseline month 3 and month 6 aBMD of lumbar spine total hip and non-dominant distal radius will be measured using dual-energy X-ray absorptiometry DXA and microarchitecture of bone is measured at the non-dominant distal radius and the second metacarpal bone of the non-dominant hand using HR-pQCT
A high-resolution peripheral quantitative computed tomography HR-pQCT capable of achieving an isotropic voxel size of 80μm at tolerable radiation doses 3μSv is available for the assessment of trabecular and cortical microarchitecture at the distal radius and tibia This technique bears excellent precision for both density and microstructure measures Denosumabs greater potency in suppressing bone remodeling and greater effect on areal BMD than alendronate particularly at predominantly cortical sites such as the distal third of the radius may reflect the differing mechanism of action of these drugs which in turn influence bone microarchitecture
The aim of this study is to compare the effects of denosumab and a current standard treatment on cortical and trabecular microarchitecture at the radius and second metacarpal in RA patients with low bone mineral density using HR-pQCT during a 6-month open-label randomized controlled study One bisphosphonate namely alendronate sodium or alendronate is chosen to generate a heterogeneous and comparable active control group This is a 6-month open-label randomized controlled clinical trial Forty ambulatory Chinese females who consent to receive alendronate as standard treatment subjective to the randomization will be enrolled from the rheumatology clinic of the Prince of Wales Hospital in this study Subjects will be randomized to 2 groups receiving 1 subcutaneous injection of denosumab 60mg Prolia every 6 months n20 or 2 a standard treatment oral alendronate weekly Fosamax once weekly 70 mg n20 In addition all patients will be given a daily calcium supplement 1500mg caltrate day and 1 multivitamin tablet per day Efficacy and safety assessment will be performed at baseline month 3 and month 6 aBMD of lumbar spine total hip and non-dominant distal radius will be measured using dual-energy X-ray absorptiometry DXA and microarchitecture of bone is measured at the non-dominant distal radius and the second metacarpal bone of the non-dominant hand using HR-pQCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None