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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267279
• Other study ID #: SJRC-Reclast
• Status: Completed
• Phase: Phase 4
• Start date: January 2005
• Est. completion date: December 2014

Study information

• Verified date: November 2018
• Source: Spokane Joint Replacement Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Zoledronic acid
Zoledronic acid per protocol

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spokane Joint Replacement Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density (BMD)	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.	2 years post-operative