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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001150
Receipt No. R000001395
Scientific Title Alendronate treatment in patients with osteoarthritis of the hip associated with osteoporosis
Date of disclosure of the study information 2008/09/01
Last modified on 2013/05/13

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Basic information
Public title Alendronate treatment in patients with osteoarthritis of the hip associated with osteoporosis
Acronym Alendronate treatment in patients with hip osteoarthritis
Scientific Title Alendronate treatment in patients with osteoarthritis of the hip associated with osteoporosis
Scientific Title:Acronym Alendronate treatment in patients with hip osteoarthritis
Region
Japan

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

Objectives
Narrative objectives1 Hypothesis: Alendronate treatment due to osteoporosis will have clinical effects in patients with hip osteoarthritis, by control of unfavorable local bone remodeling associated with hip osteoarthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 1) Plain anteroposterior radiographs of the hip (minimal joint space, position of the center of the femoral head, osteophyte, sclerotic chnage, porotic change)
2) WOMAC hip score, VAS score of the hip and knee
Evaluation will be performed at the entry of the study, 3,6,12,18,24 months after start of the study
Key secondary outcomes 1) Biochemical markers (Urinary NTX-I and CTX-II)
2) DEXA (Lumbar and hip)
3) MRI of the hip
4) Status of administration in alenronate and anti-inflamatory drugs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group A: Aspara-CA 1200mg/day administrated every day, for 2 years
Interventions/Control_2 Group B: Aspara-CA 1200mg/day administrated every day and alendronate 35mg administrated once a week , 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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1) Occurence of pain within 1 month at inclusion of the study
2) Diagnosis with osteoarthritis of the hip at the grade 2 or more according to Kellgren & Lawrence classification
3) Diagnosis with osteoporosis on Lumbar X rays
Key exclusion criteria 1) Patient who has willing to receive surgery of the hip, or who is scheduled to receive surgery of the hip, at the entry of the study
2) Patient who has willing to bear a child or who is a nursing mother
3) Patient who has serious renal disorder
4) Patient who has experiences of receiving bisphosphonate treatment within 6 months at inclusion of the study
5) Patient who has experiences of receiving drugs having influence on bone remodeling rwithin 8 weeks at inclusion of the study (Vitamin D, Calcitonin, Ipriflavone, Vitamin K, Steroid)
6) Patients with primary or secondary hyperparathyroidism, or with rheumatic arthritis
7) Patients with upper gastrointestinal disorders
8) Patients who is diagnosed as contraindication of alendronate treatements

Target sample size 210

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Nishii
Organization Osaka University Medical School
Division name Department of Orthopaedic Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3552
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Nishii
Organization Osaka University Medical School
Division name Department of Orthopaedic Surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3552
Homepage URL http://www.med.osaka-u.ac.jp/pub/ort/www/
Email nishii@ort.med.osaka-u.ac.jp

Sponsor
Institute Osaka Osteo-Arthritis Forum (OAF)
Institute
Department

Funding Source
Organization Japan Association of Preventive Medicine for Adult Disease
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 01 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
2008 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2008 Year 05 Month 11 Day
Last modified on
2013 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001395

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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