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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026507
Receipt No. R000030282
Scientific Title A Multicenter, Randomized Trial of the Inhibitory Effect of NSAIDs for APR in Primary Osteoporosis Patients Administered Zoledronic Acid
Date of disclosure of the study information 2017/03/11
Last modified on 2018/03/26

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Basic information
Public title A Multicenter, Randomized Trial of the Inhibitory Effect of NSAIDs for APR in Primary Osteoporosis Patients Administered Zoledronic Acid
Acronym OZ-study
Scientific Title A Multicenter, Randomized Trial of the Inhibitory Effect of NSAIDs for APR in Primary Osteoporosis Patients Administered Zoledronic Acid
Scientific Title:Acronym OZ-study
Region
Japan

Condition
Condition Primary Osteoporosis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate inhibitory effect of loxoprofen sodium hydrateoxonin for APR(Acute Phase Reaction) in primary osteoporosis patients administered zoledronic Acid
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of acute phase reaction
(pyrexia, arthralgia, myalgia, headache,influenza-like illness)
Body temperature
(>=1 degrees Celsius from baseline and >=37.5 degrees Celsius)
Key secondary outcomes Relationship between osteoporosis therapeutic use history in past three years and APR, changes in body temperature

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 LOX+ZOL group:
Patient takes loxoprofen sodium hydrate 60mg;twice on the day of administration of zoledronic acid, three times in the next day.
Interventions/Control_2 ZOL group:
Patient takes loxoprofen sodium hydrate 60mg as rescue medicine.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Primary osteoporosis patient
(2) Japanese patient aged over 60 years old at informed consent
(3) Patient whose history of usage of osteoporotic therapeutic drug in past three years before informed consent can be investigated
Key exclusion criteria (1) Secondary osteoporosis patient
(2) Patient has serious renal disease: creatinine clearance< 35ml/min, or serious liver disease or serious heart disease
(3) Patient has complication or history of malignant tumor in past five years
(4) Patient has history of hypersensitivity to zoledronic acid or other kinds of bisphosphonate or loxoprofen sodium hydrate
(5) Patient with hypocalcemia
(6) Patient participated in other clinical trials within 24 weeks before informed consent
(7) Others who are deemed unsuitable for inclusion in the study for any other reason based on the assessment by the investigators
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobukazu Okimoto
Organization Okimoto Clinic
Division name Department of orthopedics
Zip code
Address 185-4 Kubi, Yutakamachi, Kure-shi,Hiroshima
TEL 0823-66-2314
Email noboki4@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruhiko Miyazaki
Organization Public Health Research Foundation
Division name Comprehensive Support Project
Zip code
Address 1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo
TEL 03-5287-2639
Homepage URL
Email oz@csp.or.jp

Sponsor
Institute OZ-study group
Institute
Department

Funding Source
Organization Asahi Kasei Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 沖本クリニック(広島県)、産業医科大学病院(福岡県)、村上整形外科医院(福岡県)、かつき脳外科整形外科(福岡県)、おかもと整形外科スポーツクリニック(広島県)、小波瀬病院(福岡県)、シムラ病院(広島県)、緑井整形外科(広島県)、庄原赤十字病院(広島県)、鶴上整形外科リウマチ科(熊本県)、手島整形外科医院(福岡県)、北出病院(和歌山県)、戸畑総合病院(福岡県)、呉中通病院(広島県)、みやぎ南部整形外科クリニック(宮城県)、戸畑共立病院(福岡県)、周南高原病院(山口県)、呉医療センター中国がんセンター(広島県)、サカ緑井病院(広島県)、新小倉病院(福岡県)、赤池協同医院(福岡県)、総合病院 回生病院(香川県)、マッターホルンリハビリテーション病院(広島県)、西日本病院(熊本県)、北九州総合病院(福岡県)、三財病院(宮崎県)、東広島医療センター(広島県)、マツダ病院(広島県)、済生会呉病院(広島県)、呉共済病院(広島県)、健愛記念病院(福岡県)、くろつち福岡春日リハビリテーションクリニック(福岡県)、守口生野記念病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 11 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 Completed
Date of protocol fixation
2017 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 13 Day
Last follow-up date
2017 Year 11 Month 07 Day
Date of closure to data entry
Date trial data considered complete
2018 Year 02 Month 27 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 11 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030282

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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