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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000030828
Date of registration:	15/01/2018
Prospective Registration:	Yes
Primary sponsor:	Osaka City University Graduate School of Medicine
Public title:	The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis.
Scientific title:	The preventive effect for new vertebral fractures of zoledronic acid and denosumab combined with vitamin D in patients with rheumatoid arthritis. - EVIDENCE study
Date of first enrolment:	2018/01/15
Target sample size:	500
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035188
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Tadashi Okano
Address:	1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan Japan
Telephone:	06-6645-3851
Email:	ma1sa3ru@med.osaka-cu.ac.jp
Affiliation:	Osaka City University Graduate School of Medicine Orthopaedic Surgery

Name:	Tadashi Okano
Address:	1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan Japan
Telephone:	06-6645-3851
Email:	ma1sa3ru@med.osaka-cu.ac.jp
Affiliation:	Osaka City University Graduate School of Medicine Orthopaedic Surgery

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1) The patients with contraindication to denosumab and bisphosphonate 2) The patients who used zoledronic acid or denosumab previously 3) The patients who used teriparatide previously 4) The patients who are not included other intervention study 7) Those who are not approved to be eligible to this study by corresponding researcher

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis Osteoporosis

Intervention(s)

zoledronic acid
denosumab

Primary Outcome(s)

the incidence ratio of new vertebral fractures after two years

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Self funding

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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