UMIN-CTR Clinical Trial

Basic information
Public title	Preventive effects with teriparatide or alendronate on the progression of vertebral collapse
Acronym	T-WRAP (Teriparatide for new vertebral fractures to wedge deformity prevention study)
Scientific Title	Preventive effects with teriparatide or alendronate on the progression of vertebral collapse
Scientific Title:Acronym	T-WRAP (Teriparatide for new vertebral fractures to wedge deformity prevention study)
Region	Japan

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

Objectives
Narrative objectives1	To investigate the preventive effect of teriparatde or alendronate on the progression of vertebral collapse after osteoporotic vertebral fracture.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression of vertebral collapse fracture
Key secondary outcomes	Pain, QOL, Bone turnover markers, Bone mineral density

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Teriparatide
Interventions/Control_2	Alendronate
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	Female
Key inclusion criteria	Women with fragility vertebral compression fracture
Key exclusion criteria	1. Patients with vertebral compression fractures which is not clear the time of injury. 2. Patients received teriparatide or denosumab within 6 months prior to the study. 3. Patients with contraindications of teriparatide or alendronate. 4. Patients with severe renal dysfunction, severe liver dysfunction, or severe heart disease. 5. Inappropriate patients to participate the study judged by primary physician.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Ikeda, M.D., Ph. D.
Organization	Ken-Ai Memorial Hospital
Division name	Orthopaedic Surgeon
Zip code	8114313
Address	1191 oaza kimori. Onga-machi onga-gun. Fukuoka. 811-4313 Japan
TEL	093-293-7090
Email	s-ikeda@bc.iij4u.or.jp

Public contact
Name of contact person	1st name Kazumasa Middle name Last name Tanzawa
Organization	EPS corporation
Division name	CEO Office
Zip code	1620814
Address	1-1, Shinogawamachi, Shinjyuku-ku, Tokyo Japan
TEL	03-5684-7797
Homepage URL
Email	tanzawa517@eps.co.jp

Sponsor
Institute	Kitakyushu Osteoporosis Trial Unit
Institute
Department

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

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

IRB Contact (For public release)
Organization	Matumoto Clinic IRB Organization
Address	ST Shibuya 2F, 1-15-14 Dogenzaka, Shibuya-ku Tokyo JAPAN
Tel	03-6416-1947
Email	matsumoto@clinic-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	2014 Year 02 Month 01 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
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	2013 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2015 Year 10 Month 30 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 01 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 01 Month 30 Day
Last modified on	2019 Year 09 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015139