UMIN-CTR Clinical Trial

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

Primary Osteoporosis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

OZ-study group

Institute

Department

Personal name

Organization

Asahi Kasei Pharma Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2017

Year

03

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

03

Month

11

Day

Last modified on

2018

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030282