UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015136 |
|---|---|
| Receipt number | 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 18:19:02 |
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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
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
a.miyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
-
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017601
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