A randomised controlled trial evaluating the effects of hormone replacement therapy (HRT) on bone mineral density (BMD) and disease course in postmenopausal women with rheumatoid arthritis (RA)

ISRCTN ISRCTN46523456
DOI https://doi.org/10.1186/ISRCTN46523456
Secondary identifying numbers N/A
Submission date
03/03/2004
Registration date
22/04/2004
Last edited
30/06/2009
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

Prof Hans Carlsten
Scientific

Sahlgrenska Academy at Göteborg University
The Department of Rheumatology and Inflammation Research
Guldhedsgatan 10
Göteborg
S-413 46
Sweden

Email hans.carlsten@rheuma.gu.se

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific title
Study objectivesRheumatoid 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(s)Ethics approval received from the Ethics Committee at the Göteborg University.
Health condition(s) or problem(s) studiedRheumatoid arthritis
InterventionEighty-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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Hormone replacement therapy
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants88
Key inclusion criteria1. 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
Key exclusion criteriaDoes not comply with above inclusion criteria.
Date of first enrolment01/04/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Sweden

Study participating centre

Sahlgrenska Academy at Göteborg University
Göteborg
S-413 46
Sweden

Sponsor information

Sahlgrenska Academy at Göteborg University (Sweden)
University/education

The Department of Rheumatology and Inflammation Research
Guldhedgatan 10
Göteborg
S-413 46
Sweden

Email hans.carlsten@rheuma.gu.se
Website http://www.sahlgrenska.gu.se/english/
ROR logo "ROR" https://ror.org/01tm6cn81

Funders

Funder type

Research organisation

Regional Research Sources from Västra Götaland (Sweden)

No information available

Novo Nordisk Scandinavia AB Research Foundation (Sweden)

No information available

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

No information available

The Research Foundation of Trygg-Hansa (Sweden)

No information available

The Swedish and Göteborg Association against Rheumatism (Sweden)

No information available

Reumaforskningsfond Margareta (Sweden)

No information available

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

No information available

The Medical Society of Göteborg (Sweden)

No information available

The Medical Faculty of Göteborg (LUA) (Sweden)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2004 Yes No
Results article results 01/07/2009 Yes No