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

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ClinicalTrials.gov Identifier: NCT01267279
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
David F. Scott, MD, 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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Zoledronic acid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Study Start Date : January 2005
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo group Drug: Zoledronic acid
Zoledronic acid per protocol
Other Name: Reclast
Experimental: Study drug group Drug: Zoledronic acid
Zoledronic acid per protocol
Other Name: Reclast



Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01267279     History of Changes
Other Study ID Numbers: SJRC-Reclast
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs