Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
To investigate the effect of alendronate in Rheumatoid Arthritis (RA) patients by non-invasive assessment of vertebral strength using finite element analysis of Quantitative Computed Tomography (QCT) scans.
Ethics approval
The Internal Committee of Kyushu University, composed of various departments of the University. Approved on 01/24/2000. (Please note that this ethics committee has been replaced by an established Institutional Review Board as of 07/09/2007).
Study design
Prospective randomized controlled trial, single center.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Rheumatoid arthritis
Intervention
Treatment arm: 5 mg of oral alendronate once daily
Control arm: Standard care only
Intervention type
Drug
Phase
Not Specified
Drug names
alendronate
Primary outcome measures
Longitudinal evaluation for the following was done at baseline and at least 7 months after the baseline assessment (average follow-up was 12.15 months), and percentage change was calculated:
1. BMD assessed by Dual energy X-ray Absorptiometry (DXA)
2. Various parameters (such as bone volume fraction, vertebral compressive strength), derived from quantitative CT evaluation including finite element analysis
Secondary outcome measures
RA disease activity was assessed by Disease Activity Score (DAS-28), at least 7 months after the baseline assessment (average follow-up was 12.15 months).
Overall trial start date
01/09/2001
Overall trial end date
21/08/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Female postmenopausal patients with RA who met the American College of Rheumatology diagnostic criteria for RA.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. The presence of abnormalities on spinal radiographs such as severe osteophytosis, scoliosis, spinal fusion, fracture deformation
2. Any disease known to affect bone turnover
3. Current or past glucocorticoid therapy comprising greater than 7.5 mg/day (predonisone equivalent)
4. Current or past use of anabolic steroids, calcitonin, supplemental vitamin D or vitamin K, bisphosphonate
5. Current or past hormone replacement therapy
6. Spinal areal Bone Mineral Density (BMD) T-score greater than -1.0
Recruitment start date
01/09/2001
Recruitment end date
21/08/2003
Locations
Countries of recruitment
Japan
Trial participating centre
3-1-1 Maidashi
Fukuoka
812-8582
Japan
Funders
Funder type
Other
Funder name
The Japanese Society of Clinical Pharmacology and Therapeutics
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Japanese Osteoporosis Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary