Condition category
Musculoskeletal Diseases
Date applied
03/03/2004
Date assigned
22/04/2004
Last edited
30/06/2009
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

Prof Hans Carlsten

ORCID ID

Contact details

Sahlgrenska Academy at Göteborg University
The Department of Rheumatology and Inflammation Research
Guldhedsgatan 10
Göteborg
S-413 46
Sweden
hans.carlsten@rheuma.gu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Rheumatoid arthritis (RA) is a chronic disabling inflammatory rheumatic disease involving predominantly the joints and often also other organs such as the lungs and heart. The disease increases the risk of developing osteoporosis and fractures related to the reduced bone mineral density (BMD). The prevalence of the disease is 0.5 - 1% and women are more frequently affected.

The aims of the study were to assess the effects of HRT on:
1. The clinical disease activity
2. Laboratory measures of inflammation
3. BMD
4. Joint destruction by scoring radiographs
5. Biochemical markers of bone and cartilage metabolism
6. Pro-inflammatory cytokines and insulin like growth factor 1

Ethics approval

Ethics approval received from the Ethics Committee at the Göteborg University.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

Eighty-eight women were randomised to:
1. HRT group (41 women): receive HRT and 500 mg calcium and 400 IU vitamin D3
2. Control group (47 women): receive 500 mg calcium and 400 IU vitamin D3 alone

Intervention type

Drug

Phase

Not Specified

Drug names

Hormone replacement therapy

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Postmenopausal women with RA between 45 and 55 years old
2. Active disease, which met at least two of the following criteria:
2.1. At least six painful joints
2.2. At least three swollen joints
2.3. Erythrocyte sedimentation rate (ESR) at least 20 mm per hour
2.4. C-reactive protein (CRP) at least 10 mg/l
2.5. Fulfils the American Rheumatism Association 1987 revised criteria for adult RA
3. A maximum daily dose of 7.5 mg of prednisolone was accepted
4. Not receiving, or had not been using in the past two years, drugs affecting bone metabolism (HRT or bisphosphonates), except calcium and vitamin D3, which were allowed
5. No contra-indications to HRT

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

88

Participant exclusion criteria

Does not comply with above inclusion criteria.

Recruitment start date

01/04/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Sweden

Trial participating centre

Sahlgrenska Academy at Göteborg University
Göteborg
S-413 46
Sweden

Sponsor information

Organisation

Sahlgrenska Academy at Göteborg University (Sweden)

Sponsor details

The Department of Rheumatology and Inflammation Research
Guldhedgatan 10
Göteborg
S-413 46
Sweden
hans.carlsten@rheuma.gu.se

Sponsor type

University/education

Website

http://www.sahlgrenska.gu.se/english/

Funders

Funder type

Research organisation

Funder name

Regional Research Sources from Västra Götaland (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novo Nordisk Scandinavia AB Research Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Rune and Ulla Amlövs Foundation for Neurological and Rheumatological Research (Rune och Ulla Amlövs Stiftelse for Neurologisk och Reumatologisk Forskning) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Research Foundation of Trygg-Hansa (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish and Göteborg Association against Rheumatism (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Reumaforskningsfond Margareta (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

King Gustav V's 80-years Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Medical Society of Göteborg (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Medical Faculty of Göteborg (LUA) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nycomed (Sweden) - provided the calcium and vitamin D3 medication

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

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15380045
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19416946

Publication citations

  1. Results

    Forsblad d'Elia H, Christgau S, Mattsson LA, Saxne T, Ohlsson C, Nordborg E, Carlsten H, Hormone replacement therapy, calcium and vitamin D3 versus calcium and vitamin D3 alone decreases markers of cartilage and bone metabolism in rheumatoid arthritis: a randomized controlled trial [ISRCTN46523456]., Arthritis Res. Ther., 2004, 6, 5, R457-68, doi: 10.1186/ar1215.

  2. Results

    Pullerits R, d'Elia HF, Tarkowski A, Carlsten H, The decrease of soluble RAGE levels in rheumatoid arthritis patients following hormone replacement therapy is associated with increased bone mineral density and diminished bone/cartilage turnover: a randomized controlled trial., Rheumatology (Oxford), 2009, 48, 7, 785-790, doi: 10.1093/rheumatology/kep079.

Additional files

Editorial Notes