UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020584 |
|---|---|
| Receipt number | 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 | 2024/09/02 10:16:30 |
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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
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
kohchiba@estate.ocn.ne.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
| 2024 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023763
