UMIN-CTR Clinical Trial

Basic information
Public title	Teriparatide Once Weekly Efficacy Research for primary prevention of Glucocorticoid-induced Osteoporosis
Acronym	TOWER-GO post hoc analysis
Scientific Title	Teriparatide Once Weekly Efficacy Research for primary prevention of Glucocorticoid-induced Osteoporosis
Scientific Title:Acronym	TOWER-GO post hoc analysis
Region	Japan

Condition
Condition	Glucocorticoid-induced osteoporosis (GIOP)
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of once-weekly teriparatide formulation for the primary prevention of glucocorticoid-induced osteoporosis using post hoc analysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Rate of changes in bone mineral density of lumbar spine after 72 weeks
Key secondary outcomes	Rate of change in lumbar spine BMD after 24 and 48 weeks Ratio of the vertebral fractures Ratio of the non-vertebral fractures Rate of change in bone metabolism marker Rate of improvement in lower back pain Rate of improvement in QOL Adverse events

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	1)Objects who had not been taking oral steroid at a dose equivalent to 5mg/day of prednisolone or higher at least three months 2)Objects who was also treated by experimental drug with the once, and was estimated even sometime about the validity after treatment starting
Key exclusion criteria	none
Target sample size	78

Research contact person
Name of lead principal investigator	1st name Hisaji Middle name Last name Oshima
Organization	National Hospital Organization Tokyo Medical Center
Division name	Department of Connective tissue Diseases
Zip code	152-8902
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902 Japan
TEL	03-3411-0111
Email	hoshimamac@mac.com

Public contact
Name of contact person	1st name Terufumi Middle name Last name Yokoyama
Organization	APO PLUS STATION Co., Ltd.
Division name	CRO Business Division
Zip code	103-0027
Address	Front Place Nihonbashi, 2-14-1 Nihonbashi, Chuo-ku, Tokyo, 103-0027 Japan
TEL	03-6386-8800
Homepage URL
Email	t2-yokoyama@apoplus.co.jp

Sponsor
Institute	Glucocorticoid-induced osteoporosis research society
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	National Hospital Organization Tokyo Medical Center IRB
Address	2-5-1 Higashigaoka, Meguro-ku, Tokyo, 152-8902 Japan
Tel	03-3411-0111
Email	215-rinri@mail.hosp.go.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 09 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	78
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 05 Day
Date of IRB	2019 Year 09 Month 02 Day
Anticipated trial start date	2019 Year 09 Month 02 Day
Last follow-up date	2019 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The primary preventive effect is considered by putting post hoc analysis to the data TOWER-GO study gave into effect about the validity of once-weekly teriparatide formulation to glucocorticid-induced osteoporosis.

Management information
Registered date	2019 Year 09 Month 18 Day
Last modified on	2021 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042974