Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-jRCTs071180018
• Date of registration: 15/02/2019
• Prospective Registration: No
• Primary sponsor: Kawakami Atsushi
• Public title: Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.
• Scientific title: Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT.
• Date of first enrolment: 13/04/2018
• Target sample size: 44
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs071180018
• Study type: Interventional
• Study design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
• Phase: 4

Contacts

• Name: Atsushi Kawakami
• Affiliation: Nagasaki University Hospital

• Name: Naoki Iwamoto
• Affiliation: Nagasaki University Hospital

Key inclusion & exclusion criteria

Inclusion criteria: 1) Patients who can be visited hospital diagnosed as rheumatoid arthritis by Rheumatoid arthritis classification criteria of ACR (revised in 1987) or ACR / EULAR (2010)
2) Patients with low or moderate disease activity
3) Patients under treatment with csDMARDs.
4) Patients with progressive bone erosion in image examination (either X-ray, MRI or ultrasound)
5) Patients who are 20 years older at the time of obtaining informed consent and can consent to the document to participate by my own will
6) Male and Female
7) Outpatient only
Exclusion criteria: 1) Patients complicated of osteoporosis who have not been treated for osteoporosis
2) Patients under treatment with intravenous bisphosphonate formulation and parathyroid hormone formulation
3) Patients under treatment with Denosumab
4) Patients under treatment with Biological disease-modifying anti-rheumatic drug and JAK inhibitor
5) Patients taking adrenal cortex hormone drug in excess of 10 mg / day in terms of prednisolone
6) Patients with a history of hypersensitivity to the components of Desnomab
7) Patients with hypocalcemia
8) Patients who are or may be pregnant
9) Patients currently participating in trials or studies of other medicines or medical devices
10) Patients who are breastfeeding or who want pregnancy during the study period
11) Patients who jugged unsuitable for this study by the investigator

Age minimum: >= 20age old
Age maximum: Not applicable
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid arthritis

Intervention(s)

Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.

Primary Outcome(s)

Depth change from baseline of bone erosion by HR-pQCT measurement 6 months after starting administration.
Measurement part: second, third metacarpal bone

Secondary Outcome(s)

1.Depth change from baseline of bone erosion by HR-pQCT measurement 12 months after starting administration.
Measurement part: second, third metacarpal bone
2.Depth change from baseline of bone erosion by HR-pQCT measurement.
Measurement part: wrist joint
3.Width and Volume change from baseline of bone erosion by HR-pQCT measurement.
Measurement part: second, third metacarpal bone and wrist joint

Secondary ID(s)

UMIN000030575

Source(s) of Monetary Support

Daiichi Sankyo co.,LTD.

Ethics review

Status: Approval
Approval date: 25/01/2019
Contact:

[e-mail]

Certified Review Board, Nagasaki University

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 20/12/2022
• Date Completed: 28/04/2021
• URL: https://link.springer.com/content/pdf/10.1186/s13075-022-02957-w.pdf