UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013954 |
|---|---|
| Receipt number | R000013476 |
| Scientific Title | A multi-facility collaborative controlled trial of the effects of teriparatide on bone union in fragility fractures of patients with osteoporosis (exploratory research) |
| Date of disclosure of the study information | 2014/05/14 |
| Last modified on | 2017/11/15 09:19:01 |
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Basic information
Public title
A multi-facility collaborative controlled trial of the effects of teriparatide on bone union in fragility fractures of patients with osteoporosis (exploratory research)
Acronym
Teriparatide multi-facility collaborative controlled trial
Scientific Title
A multi-facility collaborative controlled trial of the effects of teriparatide on bone union in fragility fractures of patients with osteoporosis (exploratory research)
Scientific Title:Acronym
Teriparatide multi-facility collaborative controlled trial
Region
| Japan |
Condition
Condition
Fragility fractures due to osteoporosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of teriparatide by comparing a group treated with a combined preparation of teriparatide, active vitamin D, and calcium against a group treated with a combined preparation of active vitamin D and calcium.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Radius: Bone union following surgery in patients with distal radius fragility fractures
Femur: Bone union following surgery in patients with proximal femoral fragility fractures
Vertebral body: Bone union in conservative treatment of the vertebral body in patients with fragility fractures
The two treatment groups were compared by assessing the presence or absence of porosis in the fracture area by X-ray and CT at 8 weeks and 12 weeks following surgery to determine bone union and assessing instability in the vertebral body by X-ray.
Key secondary outcomes
QOL, bone mass measurement by DXA (lumbar spine, radius (contralateral), proximal femur), bone formation marker (serum P1NP), one resorption marker (TRACP-5b), ucOC, Ca, P, DASH, PRWE-J, grasping power, and periodic change in SF36 were compared between the two treatment groups.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Alfarol 0.5 microgram+ calcium lactate 2 x 2 g (or calcium aspartate 2 x 800 mg)/day
Interventions/Control_2
Teriparatide 56.5 microgram /week
Alfarol 0.5microgram + calcium lactate 2 x 2 g (or calcium aspartate 2 x 800 mg) /day
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 with osteoporosis who have incurred a new bone fracture [bone density (YAM value) of less than 70% for either the lumbar spine, healthy femur or healthy forearm, or previous fragility fracture (fracture due to a mild external force)] and those with radial fracture or proximal femoral fracture subject to open reduction and internal fixation (for the vertebral body, patients subject to conservative treatment).
2) Patients 20 years of age or over at the time of providing consent.
3) Patients who could provide written consent for participation.
Key exclusion criteria
1)Patients believed to be at high risk of developing the following osteosarcomas:
(1) Paget's disease of bone
(2) Patients exhibiting elevated alkaline phosphatase levels of unknown origin
(3) Infant and young patients in which the epiphysesal line is not closed
(4) Patients who have received radiation therapy believed to have affected the bones
2) Hypercalcemic patients
3) Patients with a primary malignant osteosarcoma or metastatic osteosarcoma
4) Patients with metabolic bone disease other than osteoporosis (hyperparathyroidism),
Administration was possible if, in patients with a history of secondary hyperparathyroidism, the PTH could be normalized by administration of vitamin D and calcium preparations
5) Pregnant or lactating women, or women who may be pregnant
6) Patients with a history of hypersensitivity to the agents used in this study or to similar compounds
7) Patients with kidney stones
8) Patients with severe renal failure (except when eGFR <30 mL /min/1.73 m2)
9) Patients in a comatose state or those in a state of circulatory collapse
10) Patients strongly under the effect of central nervous system depressants such as barbiturates or narcotics
11) Patients receiving administration of adrenalin
12) Patients who cannot give consent themselves (dementia, etc.)
13) Patients with a history of receiving preparations for PTH
14) Patients who are deemed unsuitable by the attending physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Murase |
Organization
Osaka University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
2-2, Yamada-oka, Suita, Osaka 565-0871
TEL
06-6879-3552
tmurase-osk@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Ebina |
Organization
Osaka University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
2-2, Yamada-oka, Suita, Osaka 565-0871
TEL
06-6879-3552
Homepage URL
k-ebina@umin.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Minoh City Hospital, Kita-Osaka Police Hospital, Osaka Koseinenkin Hospital, Hoshigaoka Koseinenkin Hospital, Kyoritsu Hospital
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 14 | 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 | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 14 | Day |
Last modified on
| 2017 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013476
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