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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronic acid

Drug

Zoledronic acid per protocol

Other names: Reclast

Placebo

Other

Placebo

Primary outcomes

Bone Mineral Density (BMD)

Time frame: 2 years post-operative

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.

Sponsors and collaborators

Lead sponsor

Spokane Joint Replacement Center

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2014
Study completion: 2014
First posted: Dec 28, 2010
Registry last updated: Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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