Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.

Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis. - Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036838

Enrollment

Registered

2019-06-03

Start date

2019-07-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who can give voluntary written informed consent. 2)Among patients who participated in the Phase III clinical study of denosumab for rheumatoid arthritis (DESIRABLE), those who were still involved in DESIRABLE at its completion (July 3, 2017). 3) Outpatients who are visiting the same institution as they visited in DESIRABLE.

Exclusion criteria

Exclusion criteria: 1)Patients without informed consent. 2)Patients who are diagnosed with osteoporosis by the time of informed consent in this study. 3)Patients who have received denosumab other than during the phase III study (DESIRABLE). 4)Patients who received bisphosphonates after the date of completion of the DESIRABLE (July 3, 2017). 5)Women who are pregnant or possibly pregnant. 6)Other patients who the investigator considers to be ineligible.

Design outcomes

Primary

Measure	Time frame
Percent change in lumbar spine bone mineral density	—

Secondary

Measure	Time frame
Changes in bone erosion score Changes in bone turnover marker (CTX-I)	—

Countries

Japan

Contacts

Public ContactHideaki Sainomoto

Daiichi Sankyo RD Novare Co., Ltd Clinical Development

sainomoto.hideaki.mb@rdn.daiichisankyo.co.jp03-5436-8542

Outcome results