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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
3-1-1 Maidashi
Higashi-ku
Fukuoka
812-8582
Japan
Study information
| Study design | Prospective randomized controlled trial, single center. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 (Please note that this ethics committee has been replaced by an established Institutional Review Board as of 07/09/2007).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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | alendronate |
| Primary outcome measure | 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 study start date | 01/09/2001 |
| Completion date | 21/08/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
812-8582
Japan
Sponsor information
Kyushu University, Department of Orthopaedic Surgery (Japan)
University/education
University/education
Graduate School of Medical Sciences
3-1-1 Maidashi
Higashi-ku
Fukuoka
812-8582
Japan
"ROR" |
https://ror.org/00p4k0j84 |
|---|
Funders
Funder type
Other
The Japanese Society of Clinical Pharmacology and Therapeutics
No information available
The Japanese Osteoporosis Foundation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
