UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Acronym	The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Scientific Title	The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Scientific Title:Acronym	The efficacy and safety of treatment with zoledronic acid in patients and the influence of patient characteristics.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficacy and safety and the influence of patient characteristics of treatment with zoledronic acid.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of change in the lumbar spine BMD.
Key secondary outcomes	The rate of change in the femoral neck BMD, the changes in type I procollagen N-terminal propeptide (P1NP), tartrate-resistant acid phosphatase-5b (TRACP-5b), VAS score of back pain, Japanese Osteoporosis Quality of Life Questionnaire (JOQOL).

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	55 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Patients who met the required inclusion criteria were enrolled in this study. 1. Patients with osteoporosis starting the treatment using ZOL from November 2016 to June 2019 at Koenji Orthopedics Clinic 2. Patients 55 years of age or older 3. Postmenopausal women who were diagnosed with primary osteoporosis
Key exclusion criteria	1. Patients with a metabolic bone disease other than osteoporosis 2. Patients with a history of hypersensitivity to the study drug or BP 3. Patients who have severe renal impairment (creatinine clearance < 35 mL/min) at the start 4. Patients who are dehydrated (high fever, severe diarrhea and vomiting, etc.) at the start 5. Patients who have hypocalcemia at the start 6. Patients whom the physicians judged to be unsuitable because of idiosyncratic complications and markedly different background
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Fumitoshi Middle name Last name Omura
Organization	Koenji Orthopedics Clinic
Division name	N/A
Zip code	166-0003
Address	4-29-2 Koenji-minami, Suginami-ku, Tokyo, Japan.
TEL	03-5377-3291
Email	oomura-f@rg7.so-net.ne.jp

Public contact
Name of contact person	1st name Fumitoshi Middle name Last name Omura
Organization	Koenji Orthopedics Clinic
Division name	N/A
Zip code	166-0003
Address	4-29-2 Koenji-minami, Suginami-ku, Tokyo, Japan.
TEL	03-5377-3291
Homepage URL
Email	oomura-f@rg7.so-net.ne.jp

Sponsor
Institute	Koenji Orthopedics Clinic
Institute
Department

Funding Source
Organization	Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japan Medical Association Ethical Review Board
Address	2-28-8 Honkomagome, Bunkyo-ku, Tokyo,Japan
Tel	03-5319-3781
Email	rinri@jmacct.med.or.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	高円寺整形外科（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 25 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.ecronicon.com/ecor/ECOR-12-00747.php
Number of participants that the trial has enrolled	88
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 01 Month 30 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 03 Month 12 Day
Date of IRB	2020 Year 04 Month 23 Day
Anticipated trial start date	2020 Year 04 Month 24 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 06 Month 09 Day
Date analysis concluded	2020 Year 07 Month 14 Day

Other
Other related information	Retrospective study

Management information
Registered date	2020 Year 11 Month 25 Day
Last modified on	2021 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048560