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Recruitment status Completed
Unique ID issued by UMIN UMIN000011846
Receipt No. 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

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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
Obsterics 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Tottori University, Faculty of Medicine, School of Health Science
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013846


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