In vivo longitudinal evaluation of vertebral bone strength in patients with rheumatoid arthritis treated with alendronate

ISRCTN	ISRCTN95526224
DOI	https://doi.org/10.1186/ISRCTN95526224
Protocol serial number	N/A
Sponsor	Kyushu University, Department of Orthopaedic Surgery (Japan)
Funders	The Japanese Society of Clinical Pharmacology and Therapeutics, The Japanese Osteoporosis Foundation

Submission date: 28/08/2007
Registration date: 10/09/2007
Last edited: 10/06/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Taro Mawatari
Scientific

3-1-1 Maidashi
Higashi-ku
Fukuoka
812-8582
Japan

Study information

Primary study design	Interventional
Study design	Prospective randomized controlled trial, single center.
Secondary study design	Randomised controlled trial
Scientific title	In vivo longitudinal evaluation of vertebral bone strength in patients with rheumatoid arthritis treated with alendronate
Study objectives	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(s)	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 (Please note that this ethics committee has been replaced by an established Institutional Review Board as of 07/09/2007).
Health condition(s) or problem(s) studied	Rheumatoid arthritis
Intervention	Treatment arm: 5 mg of oral alendronate once daily Control arm: Standard care only
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	alendronate
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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).
Completion date	21/08/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	30
Total final enrolment	30
Key inclusion criteria	Female postmenopausal patients with RA who met the American College of Rheumatology diagnostic criteria for RA.
Key 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
Date of first enrolment	01/09/2001
Date of final enrolment	21/08/2003

Locations

Countries of recruitment

Japan

Study participating centre

3-1-1 Maidashi

Fukuoka
812-8582
Japan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/11/2008	10/06/2021	Yes	No

Editorial Notes

10/06/2021: Publication reference and total final enrolment number added.