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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011419
Receipt No. R000013369
Scientific Title Efficacy of once weekly teriparatide in patients with glucocorticoid-induced osteoporosis
Date of disclosure of the study information 2013/08/08
Last modified on 2018/08/22

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Basic information
Public title Efficacy of once weekly teriparatide in patients with glucocorticoid-induced osteoporosis
Acronym TOWER-GO ( Teriparatode Once Weekly Efficacy Research for Glucocorticoid -induced Osteoporosis )
Scientific Title Efficacy of once weekly teriparatide in patients with glucocorticoid-induced osteoporosis
Scientific Title:Acronym TOWER-GO ( Teriparatode Once Weekly Efficacy Research for Glucocorticoid -induced Osteoporosis )
Region
Japan

Condition
Condition Glucocorticoid-induced osteoporosis
Classification by specialty
Medicine in general Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the change of bone mineral density at lumbar with once weekly treatment of teriparatidetreatment to glucocorticoid-induced osteoporosis compare to alendronate.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes of lumbar bone mineral density
Key secondary outcomes - Incidence of vertebral fractures
- Incidence of non-vertebral fractures
- Changes of bone turnover markers
- Pain, QOL
- Adverse events and adverse drug reactions

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 Once weekly subcutaneous injection of teriparatide acetate
Interventions/Control_2 Weekly oral administration of 35 mg alendronate with approximately 180 mL of water on rising in the morning.
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) Patients who have been taking or are scheduled to take oral steroid at a dose equivalent to 5 mg/day of prednisolone or higher for at least 3 months
2) Patients aged 20 years or older
Key exclusion criteria 1) Patients who previously used bisphosphonate. However, use for up to 2 weeks, 6 months or more before the enrollment is allowed.
2) Patients who have used Teribone or Forteo in the past.
3) Patients for who have contraindications of teriparatide and alendronate.
4) Patients who have 3 or more lumbar vertebral bodies could not be evaluated in DXA.
5) Patients who have used denosumab within the 6 months before enrollment.
6) Patients who were considered as inappropriate for the study by physician.
Target sample size 204

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1) Hisaji Oshima 2) Satoshi Soen 3) Yoshiya Tanaka 4) Ikuko Tanaka
Organization 1) National Hospital Organization Tokyo Medical Center 2) Nara Hospital Kinki University Faculty of Medicine 3) University of Occupational & Environmental Health, Japan 4) Nagoya Rheumatology Clinic
Division name 1) Department of Connective tissue Diseases 2) Department of Orthopaedic Surgery and Rheumatology 3) The First Department of Internal Medicine 4) Adviser
Zip code
Address 1) 2-5-1 Higashigaoka, Meguro-ku, Tokyo, Japan 2) 1248-1 Otoda-cho, Ikoma, Nara, Japan 3) 1-1 Iseigaoka, Yahata-nishi, Kitakyushu, Fukuoka, Japan 4) 4-26-25 Meieki, Nakamura-ku, Nagoya, Aichi, Japan
TEL 03-3411-0111
Email HOhshima@ntmc.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayumi Hasegawa
Organization APO PLUS STATION Co., Ltd.
Division name Medicine Clinical Research Dept. CRO Business Div.
Zip code
Address Front Place Nihonbashi ,2-14-1,Nihonbashi,Tokyo 103-0027,Japan
TEL 03-6386-8800
Homepage URL
Email tower-go@apoplus.co.jp

Sponsor
Institute Glucocorticoid-induced osteoporosis research group
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) DS Pharma Biomedical Co., Ltd.
TFB, INC.

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
2013 Year 08 Month 08 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 Completed
Date of protocol fixation
2013 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 26 Day
Last follow-up date
2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2018 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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