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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | 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) |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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 |
| Countries of recruitment | Sweden |
| Disease/condition/study domain | Rheumatoid arthritis |
| Participants - 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 |
| Participants - exclusion criteria | Does not comply with above inclusion criteria. |
| Anticipated start date | 01/04/2004 |
| Anticipated end date | 31/12/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 88 |
| Interventions |
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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding |
1. Regional Research Sources from Västra Götaland (Sweden)
2. Novo Nordisk Scandinavia AB Research Foundation (Sweden) 3. The Rune and Ulla Amlövs Foundation for Neurological and Rheumatological Research (Rune och Ulla Amlövs Stiftelse for Neurologisk och Reumatologisk Forskning) (Sweden) 4. The Research Foundation of Trygg-Hansa (Sweden) 5. The Swedish and Göteborg Association against Rheumatism (Sweden) 6. Reumaforskningsfond Margareta (Sweden) 7. King Gustav V's 80-years Foundation (Sweden) 8. The Medical Society of Göteborg (Sweden) 9. The Medical Faculty of Göteborg (LUA) (Sweden) 10. Nycomed (Sweden) - provided the calcium and vitamin D3 medication |
| Trial website | |
| Publications |
1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15380045
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19416946 |
| Contact name | Prof Hans Carlsten |
| Address |
Sahlgrenska Academy at Göteborg University
The Department of Rheumatology and Inflammation Research Guldhedsgatan 10 |
| City/town | Göteborg |
| Zip/Postcode | S-413 46 |
| Country | Sweden |
| hans.carlsten@rheuma.gu.se | |
| Sponsor | Sahlgrenska Academy at Göteborg University (Sweden) |
| Address |
The Department of Rheumatology and Inflammation Research
Guldhedgatan 10 |
| City/town | Göteborg |
| Zip/Postcode | S-413 46 |
| Country | Sweden |
| hans.carlsten@rheuma.gu.se | |
| Sponsor website: | http://www.sahlgrenska.gu.se/english/ |
| Date applied | 03/03/2004 |
| Last edited | 30/06/2009 |
| Date ISRCTN assigned | 22/04/2004 |
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