UMIN-CTR Clinical Trial

Basic information
Public title	Superiority of Para-thyroid hormone Therapy for Healing of bone fracture
Acronym	S-Pth study
Scientific Title	Superiority of Para-thyroid hormone Therapy for Healing of bone fracture
Scientific Title:Acronym	S-Pth study
Region	Japan

Condition
Condition	lumbar spinal stensis cervical spondylotic myelopathy
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to verify the effect of daily and weekly PTH and bisphosphonate on the surgical outcomes of lumbar spinal stnosis and cervical spondylotic myelopathy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recovery rate of JOA scores at 24 year postoperatively
Key secondary outcomes	JOACMEQ JOABPEQ SF-36 VAS bone union rate screw loosenisng rate BMD new fracture rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Bisphosphonate group as control group. This group is given Alendronate Sodium Hydrate (0.9mg/4week) from immediately after operation to 24 month after operation.
Interventions/Control_2	Daily PTH group. This group is given Teriparatide (0.02mg/day) from immediately after operation to 12 month after operation. Between 12month and 24 month after oepration, we give Calcium L-ASPARTATE(1.2g/day) to this group.
Interventions/Control_3	Weekly PTH group. This group is given Teriparatide (0.0565mg/week) from immediately after operation to 12 month after operation. Between 12month and 24 month after oepration, we give Calcium L-ASPARTATE(1.2g/day) to this group.
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	Male and Female
Key inclusion criteria	1: patient who undergone the spinal surgery for LSS or CSM 2: patieit who fullfil the criteria of osteoporosis 3: patient whose age is more than 60 y.o. 4: patient who agree with this study, with well understanding
Key exclusion criteria	1: patient who already taken the medicine for porosis before surgery. 2: patient who is tought to be hard to continue the study. 3: patient with OPLL or OYL 4: patient who is as an outpatieents of dentist 5: patient who has high risk of osteosarcoma 6: patient with hypercalcemia 7: patient with malignant tumor 8: patient with metabolic bone disease 9: patient who is taking digitalis. 10: patient with allergy for bisphosphonat or teriparatide 11: patient whose renal dysfunction 12: pregnant
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akinobu Suzuki
Organization	Osaka City University
Division name	Orthopedics
Zip code
Address	1-5-7,Asahicho,Abenoku,Osakasi,Japan
TEL	06-6645-3851
Email	a-suzuki@msic.med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Akinobu Suzuki
Organization	Osaka City University
Division name	Orthopedics
Zip code
Address	1-5-7,Asahicho,Abenoku,Osakasi,Japan
TEL	06-6645-3851
Homepage URL
Email	seikei@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Orthopedic Surgery, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 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	Terminated
Date of protocol fixation	2015 Year 09 Month 30 Day
Date of IRB	2015 Year 10 Month 16 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2016 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 30 Day
Last modified on	2020 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022555