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
Protocol serial number	N/A
Sponsor	Sahlgrenska Academy at Göteborg University (Sweden)
Funders	Regional Research Sources from Västra Götaland (Sweden), Novo Nordisk Scandinavia AB Research Foundation (Sweden), The Rune and Ulla Amlövs Foundation for Neurological and Rheumatological Research (Rune och Ulla Amlövs Stiftelse for Neurologisk och Reumatologisk Forskning) (Sweden), The Research Foundation of Trygg-Hansa (Sweden), The Swedish and Göteborg Association against Rheumatism (Sweden), Reumaforskningsfond Margareta (Sweden), King Gustav V's 80-years Foundation (Sweden), The Medical Society of Göteborg (Sweden), The Medical Faculty of Göteborg (LUA) (Sweden), Nycomed (Sweden) - provided the calcium and vitamin D3 medication

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Ethics Committee at the Göteborg University.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Hormone replacement therapy
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	88
Key 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
Key exclusion criteria	Does not comply with above inclusion criteria.
Date of first enrolment	01/04/2004
Date of final enrolment	31/12/2005

Sahlgrenska Academy at Göteborg University

Göteborg
S-413 46
Sweden

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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