UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical investigation for lumbar degenerative disease with osteoporosis to elucidate the effect of bony fusion in the presence or absence of PTH
Title of the study (Brief title)	Clinical investigation of PTH for implanted spinal surgery
Region	Japan

Condition
Condition	Osteoporosis with vertebral degeneration
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effect of PTH to induce bony fusion, decrease pseudoarthrodesis or loosening of pedicle screws, and improve clinical symptoms for aged lumbar degenerative diseases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Fusion rate Intervertebral disc narrowing and instability Appearance rate of screw loosening
Key secondary outcomes	ADL and QOL femoral bone mineral density bone metabolic markers

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Teriparatide treatment (6 months)
Interventions/Control_2	Non-treatment (6 months)
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1. Patients with lumbar degenerative disease and surgical indication for one level PLIF or TLIF. 2. Patients limited only female and more than 50 years-old. 3. Patients less than 80% YAM of any site examined by DXA, or patients with fragility fracture at any site, for example on lumbar spine, femur, radius or humerus.
Key exclusion criteria	1) The following patients considered to be at high risk of developing osteosarcoma (bone sarcoma). -Patients with Paget's disease of the bone. -Patients with high alkaline phosphatase of unknown cause. -Patients with history of radiotherapy likely to have affected the bone. 2) Patients with hypercalcaemia. 3) Patients with primary malignant osteosarcoma or metastatic bone tumor. 4) Patients with metabolic bone diseases except osteoporosis (hyperparathyroidism etc.). 5) Patients with a history of hypersensitivity to the constituents of TERIBONE for Subcutaneous Injection or other teriparatide formulations. 6) Women who are pregnant or may become pregnant.
Target sample size	60

Research contact person
Name of lead principal investigator	Hirotaka Haro, M.D., Ph.D
Organization	University of Yamanashi
Division name	Department of Orthopaedic Surgery
Address	1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL	055-273-6768
Email	haro@yamanashi.ac.jp

Public contact
Name of contact person	Yukihiro Isogai
Organization	ASAHI KASEI PHARMA Co.
Division name	Medical Affairs Dept.
Address	1-105 Kanda Jinbocho, Chiyoda-ku, Tokyo 101-8101, Japan
TEL	03-3296-3647
Homepage URL
Email	isogai.yb@om.asahi-kasei.co.jp

Sponsor
Institute	University of Yamanashi, Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization	ASAHI KASEI PHARMA Co.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Shinshu University, School of Medicine, Department of Orthopaedic Surgery Hamamatsu University School of Medicine, Department of Orthopaedic Surgery
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	2012 Year 01 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 30 Day
Anticipated trial start date	2012 Year 01 Month 30 Day
Last follow-up date	2014 Year 07 Month 01 Day
Date of closure to data entry	2015 Year 07 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 31 Day
Date analysis concluded	2015 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://journals.lww.com/jbjsjournal/subjects/Spine/Fulltext/2017/03010/Role_of_Weekly_Teriparatide_A
Results	Results: Seventy-five patients were randomized to treatment, and 66 patients completed treatment. At 4 months postoperatively, bone fusion in the 2 center CT slices was significantly higher in the teriparatide arm compared with the control arm in the age-adjusted modified intention-to-treat analysis and was significantly higher at 6 months in the per-protocol analysis. Radiographic examinations showed no disc-space narrowing and no intervertebral disc instability. JOABPEQ and ODI results were improved postoperatively in both treatment arms.
Other related information

Management information
Registered date	2012 Year 01 Month 27 Day
Last modified on	2017 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008421