Official Title
Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Phase
Phase 4Lead Sponsor
Spokane Joint Replacement CenterStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
OsteoporosisIntervention/Treatment
zoledronic acid ...Study Participants
51In 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.
Zoledronic acid per protocol
Placebo
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
| Event Type | Organ System | Event Term | Placebo | Zoledronic Acid |
|---|
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.
