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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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46523456
Enrollment
88
Registered
2004-04-22
Start date
2004-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis

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

Sponsors

Sahlgrenska Academy at Göteborg University (Sweden)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not comply with above inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026