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 2020/07/31 12:12:20

* 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

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 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

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

Value
https://center6.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