Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
- Registration Number
- NCT01267279
- Lead Sponsor
- Spokane Joint Replacement Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Zoledronic Acid Zoledronic acid -
- Primary Outcome Measures
Name Time Method Bone Mineral Density (BMD) 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.
- Secondary Outcome Measures
Name Time Method