UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Alendronate for the Prevention of Bone Loss in Calcar Region Following Total Hip Arthroplasty.
Title of the study (Brief title)	Alendronate for the Prevention of Bone Loss around Total Hip Arthroplasty.
Region	Japan

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

Objectives
Narrative objectives1	Bone mineral density loss around femoral implants, particularly in the proximal femur, is a common outcome after total hip arthroplasty. Previous studies reported the prevention of postsurgical decreases in bone mineral density with the use of osteoporosis drug therapy. This randomized study evaluates the efficacy of alendronate and alfacalcidol for preserving bone mineral density over long-term follow-up.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Periprosthetic bone mineral density measured by dual-energy X-ray(Postoperative 1-year, 2-year, 8 to 9-year)
Key secondary outcomes	Occurrence of aseptic loosening and periprsthetic fracture

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of alendronate(5mg/day) after total hip arthroplasty atleast 2 years.
Interventions/Control_2	Administration of alphacalcidolfollowing(0.001g/day) total hip arthroplasty atleast 2 years.
Interventions/Control_3	No medication after surgery at least 2 years.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent primary total hip arthroplasty for osteoarthritis at our institute
Key exclusion criteria	(a) a history of disorder(s) that might affect bone or mineral metabolism, (b) gastrointestinal disease, (c) renal dysfunction, (d) taking any agents for osteoporosis, (e) taking corticosteroids, and (f) perioperative fracture of femur that required additional fixation using plates and wires.
Target sample size	90

Research contact person
Name of lead principal investigator	Yukizawa, Yohei
Organization	Yokohama City University
Division name	Orthopaedic Surgery
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa Japan
TEL	045-787-2600
Email	snowriverjp@yahoo.co.jp

Public contact
Name of contact person	Inaba, Yutaka
Organization	Yokohama City University
Division name	Orthopaedic Surgery
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa Japan
TEL	045-787-2600
Homepage URL
Email	yute0131@med.yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2017 Year 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 08 Month 01 Day
Anticipated trial start date	2006 Year 08 Month 15 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 26 Day
Last modified on	2017 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031501