Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
This trial is active, not recruiting.
|Sponsor||Spokane Joint Replacement Center|
|Start date||January 2005|
|End date||January 2015|
|Trial size||66 participants|
|Trial identifier||NCT01267279, SJRC-Reclast|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Bone mineral density
time frame: 5 years
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
|Official title||Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty|
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