NCT01020253

Brief Summary

The purpose of this study is to evaluate whether alendronate and alfacalcidol are effective on prosthetic or lumbar spine BMD after total hip arthroplasty.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

Enrollment Period

2.2 years

First QC Date

November 24, 2009

Last Update Submit

December 2, 2009

Conditions

Bone DensityArthroplasty, Replacement, Hip

Keywords

bisphosphonate, vitamin D3Total Hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • DEXA QDR 2000, Hologic Co.

    1, 12, 24 and 48 weeks after operation

Study Arms (3)

Alendronate medication

ACTIVE COMPARATOR
Drug: alendronate, alfacalcidol

Alfacalcidol medication

ACTIVE COMPARATOR
Drug: alendronate, alfacalcidol

Non-medication

NO INTERVENTION
Drug: alendronate, alfacalcidol

Interventions

alendronate, alfacalcidolDRUG

Alendronate: 5mg per day, Tablet, Duration is 48 weeks. Alfacalcidol: 1μg per day, Tablet, Duration is 48 weeks.

Alendronate medicationAlfacalcidol medicationNon-medication

Eligibility Criteria

Age44 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteoarthritis of the hip
  • patients after total hip arthroplasty

You may not qualify if:

  • diseases related to bone metabolism
  • patients taking drugs which affect bone metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of orthopaedic surgery, Yokohama City University

Yokohama, Kanagawa, Japan

Location

MeSH Terms

Interventions

Alendronatealfacalcidol

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

January 1, 2006

Primary Completion

April 1, 2008

Last Updated

December 3, 2009

Record last verified: 2009-12

Locations

JP(1)