UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001150 |
|---|---|
| Receipt number | 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 20:09:58 |
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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
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/
nishii@ort.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka Osteo-Arthritis Forum (OAF)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001395
