Trial Outcomes & Findings for Healthy Body, Healthy Bones After Bariatric Surgery Trial (NCT NCT04279392)
NCT ID: NCT04279392
Last Updated: 2024-09-24
Results Overview
Change in hip bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) - g/cm2
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
baseline and 10 months post-surgery
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
Active Infusion
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
|
Overall Study
COMPLETED
|
2
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Active Infusion
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Healthy Body, Healthy Bones After Bariatric Surgery Trial
Baseline characteristics by cohort
| Measure |
Active Infusion
n=3 Participants
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 Participants
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.8 years
n=5 Participants
|
43.1 years
n=7 Participants
|
44.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Hip BMD
|
1.2 g/cm2
n=5 Participants
|
1.2 g/cm2
n=7 Participants
|
1.2 g/cm2
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 10 months post-surgeryPopulation: Study participants who completed the study
Change in hip bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) - g/cm2
Outcome measures
| Measure |
Active Infusion
n=2 Participants
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 Participants
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Change in Hip Bone Mineral Density (BMD)
|
0 g/cm2
Interval -0.01 to 0.01
|
-.03 g/cm2
Interval -0.07 to 0.03
|
SECONDARY outcome
Timeframe: baseline and 10 months post-surgeryPopulation: Participants who completed the study
Change in lumbar spine bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA)/cm2 of L1-L4 lumbar vertebrae
Outcome measures
| Measure |
Active Infusion
n=2 Participants
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 Participants
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Change in Lumbar Spine Bone Mineral Density (BMD)
|
.06 g/cm2
Interval 0.06 to 0.07
|
.06 g/cm2
Interval -0.06 to 0.09
|
SECONDARY outcome
Timeframe: baseline and 9 months post-surgeryPopulation: Participants who completed the study
Change in trunk lean mass, measured in kg
Outcome measures
| Measure |
Active Infusion
n=2 Participants
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 Participants
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Change in Trunk Lean Mass
|
-2.7 kg
Interval -3.6 to -1.8
|
-3.3 kg
Interval -4.4 to -1.1
|
SECONDARY outcome
Timeframe: baseline and 9 months post-surgeryPopulation: Participants who completed the study
Change in Trunk fat mass, measured in kg
Outcome measures
| Measure |
Active Infusion
n=2 Participants
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 Participants
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Change in Trunk Fat Mass
|
-1.0 kg
Interval -5.3 to 3.2
|
-5.4 kg
Interval -8.1 to -1.7
|
SECONDARY outcome
Timeframe: baseline and 9 months post-surgeryPopulation: participants who completed the study
Change in weight, measured in kgs
Outcome measures
| Measure |
Active Infusion
n=2 Participants
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 Participants
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Change in Weight
|
-10.9 kg
Interval -21.8 to 0.0
|
-22.7 kg
Interval -40.4 to -15.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 MonthsFeasibility assessment: proportion of participants completing 9 Month study visit requirements
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 MonthsComparison of the total number of adverse events reported by participants in the active and in-active arms
Outcome measures
Outcome data not reported
Adverse Events
Active Infusion
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-active Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Infusion
n=3 participants at risk
At 6 weeks post surgery, 5 mg of zoledronic acid in 100 ml of saline will be infused intravenously over a 15 minute time period.
Zoledronic Acid 5 mg/Bag 100 ml Inj: Zoledronic acid infusion
|
Non-active Infusion
n=7 participants at risk
At 6 weeks post surgery, 100 ml of saline will be infused intravenously over a 15 minute time period.
Placebos: Saline infusion
|
|---|---|---|
|
Surgical and medical procedures
Surgical Complication
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from individual participants during their participation in the study, approximately 10 months.
|
0.00%
0/7 • Adverse events were collected from individual participants during their participation in the study, approximately 10 months.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place