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

Spokane Joint Replacement Center51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoporosis

Interventions

Zoledronic acidDRUG

Zoledronic acid per protocol

PlaceboOTHER

Placebo

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bone Mineral Density (BMD)

Change in bone mineral density (BMD) (per dual energy x-ray absorptiometry (DXA) imaging) from 1 week post-operative data in the Standard and Custom Gruen Zones around the femoral stem.

Time frame: 2 years post-operative

Data from ClinicalTrials.gov

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