UMIN-CTR Clinical Trial

Basic information
Public title	Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Acronym	Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Scientific Title	Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Scientific Title:Acronym	Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Endocrinology and Metabolism Nephrology Orthopedics Oral surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Survey of major adverse events in osteoporotic patients using eldecalcitol and bisphosphonates
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of Hypercalcemia, acute kidney injury, urinary calculus, osteonecrosis of jaw, atypical femoral fracture
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with osteoporosis who started eldecalcitol or bisphosphonate
Key exclusion criteria	Patients whose gender and age information on the first prescription date cannot be confirmed
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Kondo
Organization	CHUGAI PHARMACEUTICAL CO.,LTD.
Division name	Medical Science Dept.
Zip code	103-8324
Address	1-1 Nihonbashi-Muromachi 2-Chome,Chuo-Ku Tokyo
TEL	03-3273-0866
Email	kondosts@chugai-pharm.co.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Kondo
Organization	CHUGAI PHARMACEUTICAL CO.,LTD.
Division name	Medical Science Dept.
Zip code	103-8324
Address	1-1 Nihonbashi-Muromachi 2-Chome,Chuo-Ku Tokyo
TEL	03-3273-0866
Homepage URL
Email	kondosts@chugai-pharm.co.jp

Sponsor
Institute	CHUGAI PHARMACEUTICAL CO.,LTD. Medical Science Dept.
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Non-Profit Organization MINS Institutional Review Board
Address	1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/35041084/
Number of participants that the trial has enrolled	132832
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 01 Month 18 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 09 Month 07 Day
Date of IRB	2020 Year 09 Month 16 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Database research

Management information
Registered date	2020 Year 09 Month 29 Day
Last modified on	2022 Year 02 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047866