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Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

NCT ID: NCT01267279

Last Updated: 2018-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2014-12-31

Brief Summary

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In a randomized, double-blind trial, BMD of the operated proximal femur after total hip replacement measured by dual-energy x-ray absorptiometry (DXA) were compared for up to two years in patients receiving IV ZOL 5 mg infusion (n = 27) or placebo (IV saline infusion; n = 24) at two weeks and one year after surgery.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Zoledronic Acid

Group Type EXPERIMENTAL

Zoledronic acid

Intervention Type DRUG

Zoledronic acid per protocol

Interventions

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Zoledronic acid

Zoledronic acid per protocol

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Other Intervention Names

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Reclast

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing primary elective total hip replacement

Exclusion Criteria

* Osteoporosis (BMD ≤-2.5)
* Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
* Severe renal impairment
* Use of any medications affecting BMD
* Known sensitivity to bisphosphonates
* Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Spokane Joint Replacement Center

OTHER

Sponsor Role lead

Responsible Party

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David F. Scott, MD

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SJRC-Reclast

Identifier Type: -

Identifier Source: org_study_id