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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015136
Receipt No. R000017601
Scientific Title A prospective observational study of evaluating of the effect of denosumab on bone mineral density and biochemical markers of bone turnover in postmenopausal type 2 diabetes women with low bone mass who are intractable to treatment of bisphosphonate or selective estrogen receptor modulator
Date of disclosure of the study information 2014/09/11
Last modified on 2020/03/20

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Basic information
Public title A prospective observational study of evaluating of the effect of denosumab on bone mineral density and biochemical markers of bone turnover in postmenopausal type 2 diabetes women with low bone mass who are intractable to treatment of bisphosphonate or selective estrogen receptor modulator
Acronym A prospective observational study of evaluating of the effect of denosumab on BMD and biochemical markers of bone turnover in postmenopausal T2D women with low bone mass who are intractable to treatment of bisphosphonate or SERM
Scientific Title A prospective observational study of evaluating of the effect of denosumab on bone mineral density and biochemical markers of bone turnover in postmenopausal type 2 diabetes women with low bone mass who are intractable to treatment of bisphosphonate or selective estrogen receptor modulator
Scientific Title:Acronym A prospective observational study of evaluating of the effect of denosumab on BMD and biochemical markers of bone turnover in postmenopausal T2D women with low bone mass who are intractable to treatment of bisphosphonate or SERM
Region
Japan

Condition
Condition Type 2 diabetes mellitus, Osteoporosis
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate of the effect of denosumab on bone mineral density and biochemical markers of bone turnover in postmenopausal type 2 diabetes women with low bone mass who are inactable to treatment of bisphosphonate or selective estrogen receptor modulator
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bone mineral density of femure neck and lumbar spine and biochemical markers of bone turnover
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
90 years-old >=
Gender Female
Key inclusion criteria Subjects were postmenopausal women with T2D whose YAM is less than 80% at femoral neck or lumbar spine by dual-energy X-ray absorptiometry in spite of having treatments of active type Vit.D and bisphosphonate or SERM for more than six months.
They agree to this study.
They come to our departments at regular intervals.
Key exclusion criteria We excluded the patients who were satisfied with the following conditions.
Pioglitazone or incretin related drugs may be added or adjusted in observational period.
HbA1c level is more than 10%.
Medications about diabetes mellitus were changed for four weeks before this entry.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name Hideaki
Middle name
Last name Miyoshi
Organization Hokkaido University Graduate School of Medicine
Division name Rheumatology, Endocrinology and Nephrology
Zip code 060-8648
Address Kita 15, Nishi 7, Kita-ku, Sapposo, Japan
TEL 011-706-5915
Email hmiyoshi@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Arina
Middle name
Last name Miyoshi
Organization Hokkaido University Graduate School of Medicine
Division name Rheumatology, Endocrinology and Nephrology
Zip code 060-8648
Address Kita 15, Nishi 7, Kita-ku, Sapposo, Japan
TEL 011-706-5915
Homepage URL
Email a.miyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Division of Rheumatology, Endocrinology and Nephrology
Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Takikawa municipal hosumital,Hokkaido Spinal Cord Injury Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University, Clinical Resarch and Medical Innovation Center
Address Kita 14, Nishi 5, Kita-ku, Sapposo, Japan
Tel 011-706-7061
Email -

Secondary IDs
Secondary IDs YES
Study ID_1 013-0351
Org. issuing International ID_1 Hokkaido University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 11 Day

Related information
URL releasing protocol https://med2-hokudai.jp/clinical/?clinical_category=tonyobyo
Publication of results Unpublished

Result
URL related to results and publications -
Number of participants that the trial has enrolled 48
Results In the group that changed from SERM to Dmab, the LS BMD change rate was significantly increased by 5.0% compared with the group that continued SERM (P <0.04). Serum-bone-specific ALP (BAP) and TRACP-5b were significantly reduced in each group.
Results date posted
2020 Year 03 Month 20 Day
Results Delayed
Delay expected
Results Delay Reason Under preparation
Date of the first journal publication of results
2019 Year 10 Month 12 Day
Baseline Characteristics T2D was ineffective with BP or SERM
Participant flow Regular outpatients at participating facilities
Adverse events Hypercalcemia 3 patients, renal dysfunction 1
Outcome measures Lumbar and femoral bone mineral density
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 11 Day
Date of IRB
2014 Year 07 Month 25 Day
Anticipated trial start date
2014 Year 09 Month 24 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective, observational study

Management information
Registered date
2014 Year 09 Month 11 Day
Last modified on
2020 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017601

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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