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
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
-
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.
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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.