UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Title of the study (Brief title)	Clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Region	Japan

Condition
Condition	osteoporotic vertebral factures
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of study was to clarify that clinical outcomes of combination treatment of teriparatide and denosumab for patients with osteoporotic vertebral factures
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	XP, ADL and QOL at 6 months after osteoporotic vertebral factures
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	combination treatment of teriparatide and denosumab
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients older than 65 years and with a fresh OVF
Key exclusion criteria	artificial dialysis dementia
Target sample size	15

Research contact person
Name of lead principal investigator	Motoki Iwasaki
Organization	Osaka Rosai Hospital
Division name	orthopaedics
Address	1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Osaka
TEL	0722-52-3561
Email	iwasaki@ort.med.osaka-u.ac.jp

Public contact
Name of contact person	Tomiya Matsumoto
Organization	Osaka Rosai Hospital
Division name	orthopaedics
Address	1179-3 Nagasonecho, Kita-ku, Sakai 591-8025, Osaka
TEL	0722-52-3561
Homepage URL
Email	spap44d9@bird.ocn.ne.jp

Sponsor
Institute	Osaka Rosai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka Rosai Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 03 Month 16 Day
Last modified on	2016 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019485