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
Scientific
Sahlgrenska Academy at Göteborg University
The Department of Rheumatology and Inflammation Research
Guldhedsgatan 10
Göteborg
S-413 46
Sweden
| hans.carlsten@rheuma.gu.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Hormone replacement therapy |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2004 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Sahlgrenska Academy at Göteborg University
Göteborg
S-413 46
Sweden
S-413 46
Sweden
Sponsor information
Sahlgrenska Academy at Göteborg University (Sweden)
University/education
University/education
The Department of Rheumatology and Inflammation Research
Guldhedgatan 10
Göteborg
S-413 46
Sweden
| hans.carlsten@rheuma.gu.se | |
| Website | http://www.sahlgrenska.gu.se/english/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
