UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011846
Receipt number R000013846
Scientific Title Efficacy of minodronic acid hydrate in patients with osteoporosis
Date of disclosure of the study information 2013/09/25
Last modified on 2018/03/08 19:07:11

* 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

Efficacy of minodronic acid hydrate in patients with osteoporosis

Acronym

Efficacy of minodronic acid hydrate in patients with osteoporosis

Scientific Title

Efficacy of minodronic acid hydrate in patients with osteoporosis

Scientific Title:Acronym

Efficacy of minodronic acid hydrate in patients with osteoporosis

Region

Japan


Condition

Condition

osteoporosis

Classification by specialty

Obstetrics and Gynecology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of y minodronic acid hydrate (MIN) in both naive and other bisphosphonates-treatment resistant osteoporotic patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

(1)Newly diagnosed Osteoporotic patients
-Changes in bone metabolic markers
-Changes in QOL score(SF-8)
(2) Other bisphosphonates-treatment resistant osteoporotic patients.
-Changes in bone mineral density
-Changes in hip structure analysis

Key secondary outcomes

(1)Newly diagnosed Osteoporotic patients
-Correlation between bone metabolic markers
-Correlation between the number of incident fracture and the efficacy of MIN
-Incidence of new vertebral fracture
-Adherence to MIN
- Incidence of side effects
(2) Other bisphosphonates-treatment resistant osteoporotic patients.
-Changes in bone metabolic markers
-Correlation between bone metabolic markers and bone mineral density
-Correlation between the number of incident fracture and the efficacy of MIN
-Incidence of new vertebral fracture
-Adherence to MIN
- Incidence of side effects


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients included are to be given minodronic acid hydrate

Interventions/Control_2


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

50 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1)Primary osteoporotic patients
2)Patients who take bisphosphonates more than 2 years and do not gain the bone mineral density (lumbar vertebra or hip) over 3 % since prescription of bisphosphonates
3)Age-lower limit: 50 years old, age-higher limit: none
4)Patients able to walk themselves
5)Patients giving informed consent

Key exclusion criteria

1)Secondary osteoporotic patient
2)Patients with peptic ulcers
3)Patients with history of gastrectomy or broad gastrointestinal resection 4)Patients who diagnosed malignancy
4)Patients with obstacles which delays esophagus passage of stricture of the esophagus or achalasia
5) Patients who have raised the upper part of the body for 30 minutes or it cannot be standing
6) Patients with hypersensitivity to bisphosphonates
7)Patients with receiving therapy of SERM or bisphosphonates
8)Patients with receiving therapy of drugs affecting bone metabolism within 8 weeks before study
9)Patients with hypocalcemia
10)Patients with severe hepatic and renal dusfunction and cardiovascular disease
11)Patients with pregnancy

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Hagino

Organization

Tottori University

Division name

Faculty of Medicine, School of Health Science

Zip code


Address

86 Nishimachi, Yonago-shi, Tottori, Japan

TEL

0859-38-6308

Email

hagino@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Hagino

Organization

Tottori University

Division name

School of Health Science, Faculty of Medicine

Zip code


Address

86 Nishimachi, Yonago-shi, Tottori, Japan

TEL

0859-38-6308

Homepage URL


Email

hagino@med.tottori-u.ac.jp


Sponsor or person

Institute

Tottori University, Faculty of Medicine, School of Health Science

Institute

Department

Personal name



Funding Source

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



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



Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


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 02 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2016 Year 01 Month 18 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 24 Day

Last modified on

2018 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013846


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name