CompletedNCT01267279Updated Dec 19, 2018Results posted

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

A Phase 4 interventional study of Zoledronic acid and Placebo in Osteoporosis, sponsored by Spokane Joint Replacement Center. Completed. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by Spokane Joint Replacement Center · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 51
Allocation: Randomized
Sex: All

Study 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.

Conditions studied

Osteoporosis

Browse trials for

Osteoporosis 1,675

In context

Osteoporosis

1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.

This study's enrollment of 51 is below the median of 95 across 1,152 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Spokane Joint Replacement Center is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients undergoing primary elective total hip replacement

Exclusion criteria

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

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 51 participants (actual)

Study arms

Placebo comparator
Placebo
Other: Placebo
Experimental
Zoledronic Acid
Drug: Zoledronic acid

Interventions

DrugZoledronic acid
Zoledronic acid per protocol
Also known as: Reclast
OtherPlacebo
Placebo

What researchers measure

Primary outcomes

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.
Time frame: 2 years post-operative

Results

Posted Dec 19, 2018

Participant flow

Participant flow — Overall Study
Milestone	Placebo	Zoledronic Acid
Started	24	27
Completed	22	21
Not completed	2	6

Outcome measures

PrimaryBone 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.

Time frame:: 2 years post-operative
Reported as:: Mean · Percent change

Bone Mineral Density (BMD)
Percent change	Placebo	Zoledronic Acid
Gruen Zone 1: 2 years	-3.97 ± 15.2	14.30 ± 9.8
Gruen Zone 7: 2 years	-27.3 ± 11.4	-9.58 ± 12.4

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo	0/24 (0%)	2/24 (8.3%)	0/24 (0%)
Zoledronic Acid	0/27 (0%)	3/27 (11.1%)	2/27 (7.4%)

Most frequent serious events

Most frequent serious events
Event	Placebo	Zoledronic Acid
hepatic liver massHepatobiliary disorders	1/24	0/27
THA revisionMusculoskeletal and connective tissue disorders	1/24	1/27
Liver cancerHepatobiliary disorders	0/24	1/27
Muscular atrophyMusculoskeletal and connective tissue disorders	0/24	1/27

Most frequent other events

Most frequent other events
Event	Placebo	Zoledronic Acid
Flu-like symptomsGeneral disorders	0/24	2/27

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Placebo	Zoledronic Acid	Total
Mean	61.8 (51 to 77)	60.25 (33 to 84)	61.03 (33 to 84)

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo	Zoledronic Acid	Total
Female	13	15	28
Male	11	12	23

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Placebo	Zoledronic Acid	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Placebo	Zoledronic Acid	Total
United States	24	27	51

Study locations

No study locations are listed for this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2018, 4 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 24, 2010
First posted: Dec 28, 2010
Start: Jan 2005
Primary completionActual: Dec 2014
CompletionActual: Dec 2014
Results first posted: Dec 19, 2018
Last update: Dec 19, 2018

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01267279
Lead sponsor: Spokane Joint Replacement Center
Responsible party: David F. Scott, MD (PI, Spokane Joint Replacement Center) — Principal investigator
First posted: Dec 28, 2010
Start date: Jan 2005
Primary completion: Dec 2014
Completion: Dec 2014
Results posted: Dec 19, 2018
Last update: Dec 19, 2018

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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