UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research on the effect of changing from denosumab to zoledronic acid (Multicenter collaborative retrospective observational research)
Acronym	SM201901
Scientific Title	Clinical research on the effect of changing from denosumab to zoledronic acid (Multicenter collaborative retrospective observational research)
Scientific Title:Acronym	SM201901
Region	Japan

Condition
Condition	osteoporosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We analyze bone mineral density, transition of bone metabolism markers and new fracture occurrence status in patients who changed osteoporosis treatment drug from denosumab (Dmab) to zoledronic acid (ZOL).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Bone mineral density (Lumbar spine, Proximal femur total, Femoral neck)
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Being a patient diagnosed with osteoporosis (2) Patients who are judged to be the most suitable Dmab for the treatment of osteoporosis (3) Being patient who can expect survival more than six months after administration of Dmab (4) Patients who are 20 years of age or older at the Dmab start date (5) Patients whose treatment after administration of Dmab is ZOL
Key exclusion criteria	(1) Patients undergoing treatment for malignancy (2) Patients with severe heart disease and cerebrovascular disease (3) Patients with serious diseases such as pancreas and blood (4) Patients with severe renal dysfunction or failure (for example, patients with eGFR (estimated glomerular filtration rate) less than 3.0 mL /min/1.73 m2, patients on dialysis) (5) In addition, patients that the research investigator or the doctor judged inappropriate for the target
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Toru Middle name Last name Yoshioka
Organization	Shimura Hospital
Division name	Orthopedics Department
Zip code	730-0841
Address	3-13, Funairimachi, Nakaku, Hiroshima
TEL	082-294-5151
Email	t-yossy@rc4.so-net.ne.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Yoshioka
Organization	Shimura Hospital
Division name	Orthopedics Department
Zip code	730-0841
Address	3-13, Funairimachi, Nakaku, Hiroshima
TEL	082-294-5151
Homepage URL
Email	t-yossy@rc4.so-net.ne.jp

Sponsor
Institute	Orthopedics Department, Shimura Hospital
Institute
Department

Funding Source
Organization	none
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	Nihonbashi Sakura Clinic
Address	1-9-2, nihonbashi kayabacho, chuoku, Tokyo
Tel	03-6661-9061
Email	k-hosoya@ouryokukai.jp

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	2019 Year 06 Month 28 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/32656645/
Publication of results	Published

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/32656645/
Number of participants that the trial has enrolled	30
Results	Neither clinical vertebral fractures nor X-ray morphological new vertebral fractures occurred in 30 patients evaluated for fractures at 6 months and 12 months after ZOL administration.
Results date posted	2020 Year 02 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	https://pubmed.ncbi.nlm.nih.gov/32656645/
Participant flow	https://pubmed.ncbi.nlm.nih.gov/32656645/
Adverse events	https://pubmed.ncbi.nlm.nih.gov/32656645/
Outcome measures	https://pubmed.ncbi.nlm.nih.gov/32656645/
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 03 Month 11 Day
Date of IRB	2019 Year 03 Month 19 Day
Anticipated trial start date	2019 Year 03 Month 19 Day
Last follow-up date	2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Denosumab (hereinafter: Dmab) is a useful drug that increases bone density over time and reduces fracture risk in the treatment of osteoporosis. However, it is known that the discontinuation of administration causes rebound such as overshoot of bone metabolism markers, sharp decrease of bone density, and occurrence of multiple vertebral fracture. As a precautionary measure, it is described as a precaution in the package insert of Dmab to consider the use of bone resorption suppressant when interrupting Dmab. However, it does not describe the specific medicine or the timing of switching. Therefore, the influence of switching from Dmab to zoledronic acid (hereinafter referred to as ZOL) is examined. In addition, this research will be conducted in accordance with "Ethical guidelines on medical research for human subjects" (December 22, 2014, partially revised on February 28, 2017).

Management information
Registered date	2019 Year 06 Month 24 Day
Last modified on	2020 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042330