Rheumatoid Arthritis Clinical Trial
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
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 (n=20), or 2) oral alendronate weekly (Fosamax® once weekly 70 mg, n=20). 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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - with a diagnosis of RA according to the 2010 new 2010 American College of Rheumatology/ European League Against Rheumatism classification criteria - at an age over 18 years old - have a lumbar spine, or total hip or distal radius T-score lower than -1.5 by DXA - without severe deformity in metacarpophalangeal (MCP) joints which would influence the longitudinal assessment of HR-pQCT - consent to receive alendronate if randomized to standard treatment group. Exclusion Criteria: - they have previous use of denosumab, teriparatide, alendronate or other anti-resorptive agents; - they have a history of recent major gastrointestinal (GI) tract disease (e.g. oesophagitis or GI ulceration) or have experienced any previous adverse reaction to bisphosphonate therapy; - they are receiving other bone-active drugs, such as hormonal replacement therapy, thyroxine, thiazide and diuretics; - they have conditions affecting bone metabolism; contraindications to alendronate and denosumab (uncorrected hypocalcemia); - they have unexplained hypocalcemia; - they have severe renal impairment or serum creatinine level of >200umol/L; - they are pregnant or breastfeeding; - they do not understand Chinese or are incompetent in giving consent. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin | N.t. |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline in bone volumetric density at distal radius at 6th month | Bone volumetric density is characterized by average volumetric bone mineral density (BMD) at distal radius by HR-pQCT | Baseline to 6th month | No |
Secondary | Changes from baseline in trabecular bone microarchitecture at distal radius at 6th month | Trabecular bone microarchitecture is characterized by trabecular bone volume fraction (BV/TV) at distal radius by HR-pQCT | Baseline to 6th month | No |
Secondary | Changes from baseline in bone volumetric density at the 2nd metacarpal bone at 6th month | Volumetric bone density is characterized by average volumetric bone mineral density at the 2nd metacarpal bone measured by HR-pQCT | Baseline to 6th month | No |
Secondary | Changes from baseline in trabecular bone microarchitecture at 2nd metacarpal bone at 6th month | Trabecular bone microarchitecture is characterized by trabecular bone volume fraction (BV/TV) at 2nd metacarpal head by HR-pQCT | Baseline to 6th month | No |
Secondary | Changes from baseline in areal bone density at total hip at 6th month | Areal bone density at total hip is characterized by areal bone mineral density by DXA. | Baseline to 6th months | No |
Secondary | Changes from baseline in areal bone density at lumbar spine at 6th month | Areal bone density at lumbar spine is characterized by areal bone mineral denstiy at lumbar spine by DXA | Baseline to 6th month | No |
Secondary | Changes in areal bone density at distal radius at 6th month | Areal bone density is characterized by areal bone mineral density at distal radius by DXA | Baseline to 6th month | No |
Secondary | Changes from baseline in bone volumetric density at distal radius at 3rd month | Bone volumetric density is characterized by average volumetric bone mineral density (BMD) at distal radius by HR-pQCT | Baseline to 3rd month | No |
Secondary | Changes from baseline in trabecular bone microarchitecture at distal radius at 3rd month | Trabecular bone microarchitecture is characterized by trabecular bone volume fraction (BV/TV) at distal radius by HR-pQCT | Baseline to 3rd month | No |
Secondary | Changes from baseline in bone volumetric density at the 2nd metacarpal bone at 3rd month | Volumetric bone density is characterized by average volumetric bone mineral density at the 2nd metacarpal bone measured by HR-pQCT | Baseline to 3rd month | No |
Secondary | Changes from baseline in trabecular bone microarchitecture at 2nd metacarpal bone at 3rd month | Trabecular bone microarchitecture is characterized by trabecular bone volume fraction (BV/TV) at 2nd metacarpal head by HR-pQCT | Baseline to 3rd month | No |
Secondary | Changes from baseline in areal bone density at total hip at 3rd month | Areal bone density at total hip is characterized by areal bone mineral density by DXA. | Baseline to 3rd month | No |
Secondary | Changes from baseline in areal bone density at lumbar spine at 3rd month | Areal bone density at lumbar spine is characterized by areal bone mineral denstiy at lumbar spine by DXA | Baseline to 3rd month | No |
Secondary | Changes in areal bone density at distal radius at 3rd month | Areal bone density is characterized by areal bone mineral density at distal radius by DXA | Baseline to 3rd month | No |
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