Overview

This trial is active, not recruiting.

Condition osteoporosis
Treatment zoledronic acid
Phase phase 4
Sponsor Spokane Joint Replacement Center
Start date January 2005
End date January 2015
Trial size 66 participants
Trial identifier NCT01267279, SJRC-Reclast

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
zoledronic acid Reclast
Zoledronic acid per protocol
(Experimental)
zoledronic acid Reclast
Zoledronic acid per protocol

Primary Outcomes

Measure
Bone mineral density
time frame: 5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Spokane Joint Replacement Center.