Condition category
Musculoskeletal Diseases
Date applied
28/08/2007
Date assigned
10/09/2007
Last edited
20/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Taro Mawatari

ORCID ID

Contact details

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

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 (Please note that this ethics committee has been replaced by an established Institutional Review Board as of 07/09/2007).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

Sponsor information

Organisation

Kyushu University, Department of Orthopaedic Surgery (Japan)

Sponsor details

Graduate School of Medical Sciences
3-1-1 Maidashi
Higashi-ku
Fukuoka
812-8582
Japan

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes