UMIN-CTR Clinical Trial

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
Email	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
Email	yoshidtk@takii.kmu.ac.jp

Sponsor
Institute	Department of Urology and Andrology, Kansai Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021896