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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019874
Receipt No. R000022923
Scientific Title The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Date of disclosure of the study information 2015/11/20
Last modified on 2018/05/07

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Basic information
Public title The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Acronym Prevention of stress shielding with risedoronate and denosumab
Scientific Title The Effect of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Scientific Title:Acronym Prevention of stress shielding with risedoronate and denosumab
Region
Japan

Condition
Condition Osteoarthritis of the hip
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of Rsedronate and Denosumab on Periprosthetic Bone Remodeling Following Total Hip Arthroplasty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The percentage change in periprosthetic bone mineral density
Key secondary outcomes The change in bone mineral density of the vertebra, The percentage change in bone metabolic markers of resorption and formation, Harris Hip Score, Periprosthetic X-ray change

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 subcutaneous injection denosumab, 60mg every 6 months use for 2 years
Interventions/Control_2 oral risedronate, 17.5mg once weekly, use for 2 years
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
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Osteoarthritis of the hip
2) Young Adult Mean< 80% / Proximal femur or Lumbar vertebra
Key exclusion criteria 1) oral Bisphosphonate therapy for more than 3 years
2) oral Bisphosphonate therapy within 6 months prior to the study enrollment
3) oral Bisphosphonate therapy for more than 2 weeks between 6 months and 3 years prior to the study enrollment
4) intravenous Bisphosphonate therapy within 5 years prior to the study enrollment
5) Parathyroid hormone therapy within 6 weeks prior to the study enrollment
6) A history of Osteotomy
7) sever renal dysfunction (GFR< 30)
8) sever liver dysfunction
9) malignant tumor
10) hypocalcemia, hypokalemia
11) A history ofesophagostenosis, esophageal achalasia
12) A history of hyperparathyroidism
13) glucocorticoids therapy
14) pregnant woman
15) The patients should be excluded, who have poor medical compliance, drug-induced allergy, etc.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Hirakawa
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopedic
Zip code
Address 5-4-17 Dai,Kamakura,Kanagawa
TEL 0466-47-2377
Email mail@skjrc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nariaki Nakura
Organization Shonan Kamakura Joint Reconstruction Center
Division name Department of Orthopedic
Zip code
Address 5-4-17 Dai, Kamakura, Kanagawa
TEL 0466-47-2377
Homepage URL
Email izumi.kokubun@tokushukai.jp

Sponsor
Institute Shonan Kamakura Joint Reconstruction Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 医療法人沖縄徳洲会 湘南鎌倉人工関節センター
(Shonan Kamakura Joint Reconstruction Center)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 20 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
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 No longer recruiting
Date of protocol fixation
2015 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 24 Day
Last follow-up date
2018 Year 09 Month 30 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 11 Month 20 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022923

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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