UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013954
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email k-ebina@umin.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013476

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.