UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration on local and systemic bone metabolism during healing period after vertebral fracture.
Title of the study (Brief title)	To test different effects of daily and weekly teriparatide on local and systemic bone metabolism during fracture healing after vertebral fracture
Region	Japan

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

Objectives
Narrative objectives1	To clarify different effects of daily and weekly hPTH(1-34), teriparatide, administration during healing period after vertebral fracture on the fracture site, pain and systemic bone turnover, and different indication of those two agents.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Bone metabolic markers
Key secondary outcomes	Vertebral and femoral bone mineral density, numbers of new vertebral fractures during the study period, VAS, JOQOL, RDQ, QUEST, and bony union

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Teriparatide Acetate
Interventions/Control_2	Teriparatide (Genetical Recombination)
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Post-menopausal women of 60-y-o or above with sever osteoporosis who have a fresh vertebral fracture and understand, and literary approve to be included to this study. #1; The fresh vertebral fracture, what occur during 2 weeks, is defined with history, physical examination and X-ray appearances and/or MRI of spine. #2; The sever osteoporosis is diagnosed to a patient whose point is accounting for 3 or above by our appraisal standard as follow. Point 70%YAM>BMD=/>65% 1 65%YAM>BMD=/>60% 2 60%YAM>BMD 3 New vertebral fracture 1 Using corticosteroid 1 Old vertebral fracture =1 1 Old vertebral fractures >1 2 Sever osteoporosis: total 3=/<
Key exclusion criteria	1. Patients in whom study drugs (teriparatide) are contraindicated 2. Serious renal, hepatic, or cardiac disease 3. Secondly osteoporosis 4. Patients who are considered inappropriate for enrollment by the investigator for any other reason
Target sample size	40

Research contact person
Name of lead principal investigator	Shinya Tanaka
Organization	Saitama Medical University
Division name	Department of Orthopaedic Surgery
Address	Morohongo 38, moroyamacho, Irumagun, Saitamaken, Japan
TEL	049-276-1238
Email	tnk_sny@saitama-med.ac.jp

Public contact
Name of contact person	Shinya Tanaka
Organization	Saitama Medical University
Division name	Department of Orthopaedic Surgery
Address	350-0495, Morohongo 38, Moroyama-cho, Iruma-gun, Saitama, Japan
TEL	049-276-1238
Homepage URL
Email	tnk_sny@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Japan Osteoporosis Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

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	埼玉医科大学病院（埼玉県）、埼玉医科大学かわごえクリニック（埼玉県）、小川日本赤十字病院（埼玉県）、関越病院(埼玉県)、若葉病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 28 Day
Anticipated trial start date	2012 Year 08 Month 06 Day
Last follow-up date	2014 Year 03 Month 31 Day
Date of closure to data entry	2014 Year 07 Month 31 Day
Date trial data considered complete	2014 Year 07 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 03 Day
Last modified on	2017 Year 10 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010119