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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020584
Receipt No. R000023763
Scientific Title Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate on bone microarchitecture in patients with primary osteoporosis: A HR-pQCT study
Date of disclosure of the study information 2016/01/17
Last modified on 2020/07/31

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Basic information
Public title Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate on bone microarchitecture in patients with primary osteoporosis: A HR-pQCT study
Acronym Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate in patients with primary osteoporosis
Scientific Title Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate on bone microarchitecture in patients with primary osteoporosis: A HR-pQCT study
Scientific Title:Acronym Comparative effect of daily teriparatide, weekly teriparatide, or bisphosphonate in patients with primary osteoporosis
Region
Japan

Condition
Condition Primary osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of daily teriparatide, weekly teriparatide, and oral bisphosphonate on bone microarchitecture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of cortical thickness changes after 18 months
Key secondary outcomes The change of bone mineral density, bone microarchitecture, geometry and strength after 18 and 24 months

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 daily teriparatide
Interventions/Control_2 weekly teriparatide
Interventions/Control_3 oral bisphosphonate
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
89 years-old >=
Gender Female
Key inclusion criteria 1) Primary osteoporosis patients with one or more previous fragility fractures (e.g., proximal femoral fracture, vertebral fracture, distal radius fracture, proximal humerus fracture, rib fracture, pelvic fracture, lower leg fracture)
2) A written informed consent for the participation in the study
Key exclusion criteria 1)Patients with serious cardiac disorder, serious liver dysfunction, serious kidney dysfunction, diabetes mellitus, endocrine and metabolic diseases which may affect to the bone metabolism, and secondary osteoporosis (e.g., glucocorticoid-induced osteoporosis, rheumatoid arthritis, immobilization osteoporosis)
2)Patients treated with medication which affect to the bone metabolism as follows,
i)Glucocorticosteroids (within 6 months before enrollment, or >5mg for over 3 months) except inhaler or nasal drip
ii)Anti-cancer drugs
iii)Anti-osteoporosis drugs (teriparatide, anti-RANKL antibody, bisphosphonates within 6 months before enrollment, SERMs within 3 months before enrollment, or estrogen preparations)
3)Patients who have contraindication of teriparatide or bisphosphonate
4)Patients who have severe allergy
5)Patients enrolled in other clinical studies in the past 3 months.
6)Patients judged to be inadequate for this study by investigators
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Osaki
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL 095-819-7321
Email mosaki@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Ko
Middle name
Last name Chiba
Organization Nagasaki University Hospital
Division name Department of orthopaedic surgery
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL 095-819-7321
Homepage URL
Email kohchiba@estate.ocn.ne.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation, Eli Lily Japan K.K.
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 Nagasaki University Hospital Clinical Research Ethics Committee
Address 1-7-1 Sakamoto, Nagasaki
Tel 095-819-7229
Email gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 15122101
Org. issuing International ID_1 Clinical reserch, Nagasaki University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎大学病院(長崎県)/ Nagasaki University Hospital (Nagasaki prefecture)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 17 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
2015 Year 12 Month 25 Day
Date of IRB
2015 Year 12 Month 21 Day
Anticipated trial start date
2016 Year 01 Month 18 Day
Last follow-up date
2020 Year 03 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
2016 Year 01 Month 15 Day
Last modified on
2020 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023763

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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