The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity.

The effects of denosumab compared with oral bisphosphonates (BP) in patients with RA complicated with osteoporosis on the progression of structural damage, BMD and disease activity. - Two Birds trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014737

Enrollment

286

Registered

2014-08-01

Start date

2014-08-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

rheumatoid arthritis

Interventions

Denosumab group: Denosumab 60mg is administered by subcutaneous injections every 6 months (at baseline, at 6 months and at 12 months). All patients are to take vitamin D. BP group: Patients take BP co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) The presence of RA, as classified according to the ACR 2010 criteria (2) Age: from 50 years old to less than 90 years old (3) BP for more than 6 months (4) Each patients gave written informed concent.

Exclusion criteria

Exclusion criteria: (1) Use of a biologics agent for RA within 8 weeks before trial (2) Use of JAK inhibitor (3) Gulcocorticoid dose >10mg/day (prednisone or equivalent) (4) Patients whom the doctor judged unsuitable for participation from medical reason.

Design outcomes

Primary

Measure	Time frame
The change in mTSS from baseline to 52 weeks	—

Secondary

Measure	Time frame
The changes from baseline to 52 weeks in DAS28,SDAI,CDAI and BMD	—

Countries

Japan

Contacts

Public ContactAkiko Suda

Yokohama City University Medical Center Center for Rheumatic diseases

sakiko@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026