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

Spokane Joint Replacement Center

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Other: Placebo; Drug: Zoledronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01267279

SJRC-Reclast

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Zoledronic Acid

Experimental group

Treatment:

Drug: Zoledronic acid