UMIN-CTR Clinical Trial

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

osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Bone mineral density (Lumbar spine, Proximal femur total, Femoral neck)

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Orthopedics Department, Shimura Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nihonbashi Sakura Clinic

Address

1-9-2, nihonbashi kayabacho, chuoku, Tokyo

Tel

03-6661-9061

Email

k-hosoya@ouryokukai.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

06

Month

28

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/32656645/

Publication of results

Published

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

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 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).

Registered date

2019

Year

06

Month

24

Day

Last modified on

2020

Year

12

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042330