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

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zoledronic acid
Placebo
Sponsored by
Spokane Joint Replacement Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Zoledronic Acid

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 24, 2010
    Last Updated
    November 27, 2018
    Sponsor
    Spokane Joint Replacement Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01267279
    Brief Title
    Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
    Official Title
    Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spokane Joint Replacement Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Zoledronic Acid
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Zoledronic acid
    Other Intervention Name(s)
    Reclast
    Intervention Description
    Zoledronic acid per protocol
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Bone Mineral Density (BMD)
    Description
    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.
    Time Frame
    2 years post-operative

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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

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