Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty
1 other identifier
interventional
51
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2005
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 24, 2010
CompletedFirst Posted
Study publicly available on registry
December 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
December 19, 2018
CompletedDecember 19, 2018
November 1, 2018
9.9 years
December 24, 2010
October 17, 2018
November 27, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Placebo
PLACEBO COMPARATORZoledronic Acid
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients undergoing primary elective total hip replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Principal Investigator
- Organization
- Spokane Joint Replacement Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
December 24, 2010
First Posted
December 28, 2010
Study Start
January 1, 2005
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 19, 2018
Results First Posted
December 19, 2018
Record last verified: 2018-11