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

History of Changes

Tracking Information
First Received Date ^ICMJE	December 24, 2010
Last Updated Date	December 12, 2012
Start Date ^ICMJE	January 2005
Estimated Primary Completion Date	January 2015 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 27, 2010)	Bone mineral density [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01267279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
Official Title ^ICMJE	Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Osteoporosis
Intervention ^ICMJE	Drug: Zoledronic acid Zoledronic acid per protocol Other Name: Reclast
Study Arm (s)	Placebo Comparator: Placebo group Intervention: Drug: Zoledronic acid Experimental: Study drug group Intervention: Drug: Zoledronic acid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	66
Completion Date	Not Provided
Estimated Primary Completion Date	January 2015 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01267279
Other Study ID Numbers ^ICMJE	SJRC-Reclast
Has Data Monitoring Committee	No
Responsible Party	David F. Scott, MD, Spokane Joint Replacement Center
Study Sponsor ^ICMJE	Spokane Joint Replacement Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Spokane Joint Replacement Center
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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