UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Acronym	Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Scientific Title	Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Scientific Title:Acronym	Effect of Once-Weekly Teriparatide for Bisphosphonate-Resisitance Glucocorticoid-Induced Osteoporosis (TeriGo)
Region	Japan

Condition
Condition	Glucocorticoid-Induced Osteoporosis
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Pneumology Nephrology Neurology Clinical immunology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of switching to weekly teriparatide with the continuation of bisphosphonate in patients with glucocorticoid-induced osteoporosis who is taking bisphosphonate.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome is the change of bone mineral density in hip and lumbar spine (L1-4).
Key secondary outcomes

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	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Teriparatide arm: Patients receive weekly teriparatide with a discontinuation of bisphosphonate. At week 72, patients stop receiving teriparatide and are switched back to bisphosphonate. At week 144, final observation is performed.
Interventions/Control_2	Bisphosphonate arm: Patients continue to receive residual bisphosphonate until week 144.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Age at 20 yaers old or more. 2) Paitnets who recieve glucocorticoid (PSL 5mg or more) and bisphosphonate more than 6 months. 3) BMD of lumber spine (L1-4) or hip (neck or total) by DEXA is T-score of -2.0 or less, or T-score of -1.0 or less who have a history of fragility fracture. 4) Written informed consent required.
Key exclusion criteria	1) Patients whose BMD of 3 or more of lumbar spines cannot be analysed because of fracture or artificial materials. 2) Contraindication for bisphosphonate or teriparatide. 3) Patients who have received teriparatide or denosumab. 4) Patients with active infection or malignancy. 5) Age less than 20 years old. 6) Patients who is currently pregnant, breastfeeding or willing to get pregnant. 7) Patients who do not give consent to the study. 8) Patients who are judged to be inappropriate by the physician.
Target sample size	150

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Hajime Kono / Toshihiro Nanki
Organization	Teikyo University School of Medicine (Hajime Kono) Toho University School of Medicine (Toshihiro Nanki)
Division name	Department of Internal Medicine (Hajime Kono) Division of Rheumatology, Department of Internal Medicine (Toshihiro Nanki)
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan (Hajime Kono)/6-11-1 Omori-nishi, Ota-ku, Tokyo 143-8541, Japan (Toshihiro Nanki)
TEL	03-3762-4151(6851)
Email	toshihiro.nanki@med.toho-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Hajime Kono / Toshihiro Nanki
Organization	Teikyo University School of Medicine (Hajime Kono) Toho University School of Medicine (Toshihiro Nan
Division name	Department of Internal Medicine (Hajime Kono) Division of Rheumatology, Department of Internal Medic
Zip code
Address	2-11-1 Kaga, Itabashi-ku, Tokyo 173-8601, Japan (Hajime Kono)/6-11-1 Omori-nishi, Ota-ku, Tokyo 143-
TEL	03-3762-4151(6851)
Homepage URL
Email	toshihiro.nanki@med.toho-u.ac.jp

Sponsor
Institute	Teikyo University School of Medicine (Hajime Kono) Toho University School of Medicine (Toshihiro Nanki)
Institute
Department

Funding Source
Organization	Asahi Kasei Pharma Corp.
Organization
Division
Category of Funding Organization	Profit organization
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	帝京大学医学部附属病院（東京都）、熊本大学医学部附属病院（熊本県）、香川大学医学部附属病院（香川県）、 国家公務員共済組合連合会横浜南共済病院（神奈川県）、東京都健康長寿医療センター（東京都）、横浜市立大学病院（神奈川県）、宇多津病院（香川県）、善仁会市民の森病院（宮崎県）、兵庫医科大学病院（兵庫県）、さぬき市民病院（香川県）、ひろせクリニック（埼玉県）、医療法人財団医道会十条武田リハビリテーション病院（京都府）、徳島大学病院（徳島県）、下北沢病院（東京都）、そしがや大蔵クリニック（東京都）、ひらまつ内科（東京都）、川崎市立川崎病院（神奈川県）、東京都立墨東病院（東京都）、多摩総合医療センター（東京都）、埼玉医科大学病院（埼玉県）、東京女子医科大学附属膠原病リウマチ痛風センター（東京都）、香音クリニック（山形県）、市立札幌病院（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 25 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 12 Month 14 Day
Date of IRB	2015 Year 10 Month 13 Day
Anticipated trial start date	2016 Year 04 Month 25 Day
Last follow-up date	2019 Year 04 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 19 Day
Last modified on	2019 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025343