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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier:
NCT01267279
First received: December 24, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Osteoporosis
Drug: Zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: January 2005
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01267279     History of Changes
Other Study ID Numbers: SJRC-Reclast
Study First Received: December 24, 2010
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014