UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018926 |
|---|---|
| Receipt number | R000021896 |
| Scientific Title | Efficacy of minodronate and denosumab for bone loss in patients with prostate cancer undergoing androgen deprivation therapy |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2020/12/09 14:07:18 |
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Basic information
Public title
Efficacy of minodronate and denosumab for bone loss in patients with prostate cancer undergoing androgen deprivation therapy
Acronym
the PROMADE (prevention of osteopenia with minodronate and denosumab) study
Scientific Title
Efficacy of minodronate and denosumab for bone loss in patients with prostate cancer undergoing androgen deprivation therapy
Scientific Title:Acronym
the PROMADE (prevention of osteopenia with minodronate and denosumab) study
Region
| Japan |
Condition
Condition
Osteopenia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of minodronate and denosumab for bone loss in men with prostate cancer treated with androgen deprivation therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The percentage change in spine BMD
Key secondary outcomes
The percentage change in total hip and femoral neck
The percentage changes in bone markers of resorption and formation
The incidence of skeletal-related event
The incidence of adverse events in minodronate and denosumab treatment
The Adherence of minodronate and denosumab
The efficacy of each drug(the percentage change in BMD, The percentage changes in bone markers )
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral monthly minodronate,
50 mg once monthly, use for 1year
Interventions/Control_2
subcutaneous injection of
denosumab, 60 mg every 6 months
use for 1 year
Interventions/Control_3
observation (contorol) for 1 year
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1)ECOG performance status 0-1
2)Androgen deprivation therapy planned more than next one year
3) Androgen deprivation therapy<1 yr
,or Androgen deprivation therapy>1 yr and Young Adult Mean<90%
Key exclusion criteria
1)Bone metastasis
2)Castration resistance prostate cancer
3)hypocalcaemia Ca<8mg/dl
4)Androgen deprivation therapy>1 yr
and Young Adult Mean>90%
5)Prior treatment with a bisphosphonate, RANKL, parathyroid hormone
6)Prior treatment with a glucocorticoids
7)Under treatment of tooth
8)A history of achalasia
9)Estimated glomerular filtration rate <35 ml/min
10)Liver function tests>1.5 times the upper limit of normal
11)Bilateral hip replacement
12)A history of metabolic bone
disease (Paget disease, hyperparathyroidism, osteomalacia, untreated hypothyroidism)
13) The patients should be excluded
,Who have poor medical compliance, drug-induced allergy, etc.
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshida |
Organization
Kansai Medical University
Division name
Department of Urology and Andrology
Zip code
573-1191
Address
Shin-machi 2-5-1, Hirakata, Osaka 573-1010, Japan
TEL
072-804-2083
yoshidtk@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshida |
Organization
Kansai Medical University
Division name
Department of Urology and Andrology
Zip code
573-1191
Address
Shin-machi 2-5-1, Hirakata, Osaka 573-1010, Japan
TEL
072-804-2083
Homepage URL
yoshidtk@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Urology and Andrology, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethic Committee of Kansai medical university
Address
2-3-1 Shin-Machi, Hirakata, 573-1191, Osaka, Japan
Tel
072-804-2083
kenkyu@hirakata.kmu.ac.jp
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
関西医科大学附属枚方病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 14 | 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
102
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 | 09 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 07 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021896
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| Registered date | File name |
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