Rheumatoid Arthritis | RA Denosumab on Bone Microstructure Study
Rheumatoid Arthritis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:DenosumabSubcutaneous injection of denosumab 60mg every 6 months (1 dose for study period)
Drug:AlendronateAlendronate 70mg once weekly
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
DenosumabPatients in this arm will receive subcutaneous injection of denosumab 60mg every 6 months (1 dose for the study period).
Standard treatmentPatients (n=20) in this arm will receive oral alendronate (Fosamax®)70mg once.
Start Date: December 2012
Completed Date: June 2014
Phase: Phase 4
Primary Outcome: Changes from baseline in bone volumetric density at distal radius at 6th month
Secondary Outcome: Changes from baseline in trabecular bone microarchitecture at distal radius at 6th month
Study sponsors, principal investigator, and references
Principal Investigator: Lai-Shan Tam, MD
Lead Sponsor: Chinese University of Hong Kong