Trial Outcomes & Findings for Effect of Zoledronic Acid on Femoral Bone Loss Following Total Hip Arthroplasty (NCT NCT01267279)
NCT ID: NCT01267279
Last Updated: 2018-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
2 years post-operative
Results posted on
2018-12-19
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
|
Zoledronic Acid
Zoledronic acid: Zoledronic acid per protocol
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Placebo
n=24 Participants
Placebo
|
Zoledronic Acid
n=27 Participants
Zoledronic acid: Zoledronic acid per protocol
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
n=24 Participants
|
60.25 Years
n=27 Participants
|
61.03 Years
n=51 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=24 Participants
|
15 Participants
n=27 Participants
|
28 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=24 Participants
|
12 Participants
n=27 Participants
|
23 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
27 participants
n=27 Participants
|
51 participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 2 years post-operativeChange 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.
Outcome measures
| Measure |
Placebo
n=22 Participants
Placebo
|
Zoledronic Acid
n=21 Participants
Zoledronic acid: Zoledronic acid per protocol
|
|---|---|---|
|
Bone Mineral Density (BMD)
Gruen Zone 1: 2 years
|
-3.97 Percent change
Standard Deviation 15.2
|
14.30 Percent change
Standard Deviation 9.8
|
|
Bone Mineral Density (BMD)
Gruen Zone 7: 2 years
|
-27.3 Percent change
Standard Deviation 11.4
|
-9.58 Percent change
Standard Deviation 12.4
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Zoledronic Acid
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=24 participants at risk
Placebo
|
Zoledronic Acid
n=27 participants at risk
Zoledronic acid: Zoledronic acid per protocol
|
|---|---|---|
|
Hepatobiliary disorders
hepatic liver mass
|
4.2%
1/24 • Number of events 1
|
0.00%
0/27
|
|
Musculoskeletal and connective tissue disorders
THA revision
|
4.2%
1/24 • Number of events 1
|
3.7%
1/27 • Number of events 1
|
|
Hepatobiliary disorders
Liver cancer
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular atrophy
|
0.00%
0/24
|
3.7%
1/27 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=24 participants at risk
Placebo
|
Zoledronic Acid
n=27 participants at risk
Zoledronic acid: Zoledronic acid per protocol
|
|---|---|---|
|
General disorders
Flu-like symptoms
|
0.00%
0/24
|
7.4%
2/27 • Number of events 2
|
Additional Information
Principal Investigator
Spokane Joint Replacement Center
Phone: 509-466-6393
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place