Trial Outcomes & Findings for Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery (NCT NCT03424239)
NCT ID: NCT03424239
Last Updated: 2021-04-29
Results Overview
The primary aim of this study is to determine the postoperative changes in serum markers of bone turnover after a preoperative infusion of zoledronic acid. Serum C-terminal telopeptide of type 1 collagen (CTX) is marker of bone resorption.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-04-29
Participant Flow
Participant milestones
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
Baseline/Zoledronic Acid Administration
|
4
|
|
Overall Study
2 Week Post-op
|
4
|
|
Overall Study
12 Week Post-op
|
4
|
|
Overall Study
24 Week Post-op
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Pilot Study for Zoledronic Acid to Prevent Bone Loss After Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Weight
|
226.0 lb
STANDARD_DEVIATION 18.0 • n=5 Participants
|
|
BMI
|
40.9 kg/m^2
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Subtotal body fat
|
46.9 kg
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Subtotal body lean mass
|
49.8 kg
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Serum calcium
|
9.4 mg/dl
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Serum creatinine
|
0.72 mg/dl
STANDARD_DEVIATION 0.14 • n=5 Participants
|
|
Serum 25-hydroxyvitamin D
|
39.8 ng/ml
STANDARD_DEVIATION 14.8 • n=5 Participants
|
|
Serum parathyroid hormone (PTH)
|
43.5 pg/ml
STANDARD_DEVIATION 20.6 • n=5 Participants
|
|
Serum CTX
|
0.226 ng/ml
STANDARD_DEVIATION 0.163 • n=5 Participants
|
|
Serum Procollagen 1 Intact N-Terminal Propeptide (P1NP)
|
35.6 ug/l
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
DXA Spine areal bone mineral density (aBMD)
|
1.065 g/cm^2
STANDARD_DEVIATION 0.095 • n=5 Participants
|
|
DXA Femoral neck aBMD
|
0.811 g/cm^2
STANDARD_DEVIATION 0.124 • n=5 Participants
|
|
DXA Total hip aBMD
|
0.953 g/cm^2
STANDARD_DEVIATION 0.124 • n=5 Participants
|
|
QCT Trabecular spine volumetric bone mineral density (vBMD)
|
114 mg/cm^3
STANDARD_DEVIATION 41 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsThe primary aim of this study is to determine the postoperative changes in serum markers of bone turnover after a preoperative infusion of zoledronic acid. Serum C-terminal telopeptide of type 1 collagen (CTX) is marker of bone resorption.
Outcome measures
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Change in Serum CTX
|
0.228 ng/ml
Standard Deviation 0.117
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsEarly changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Change in Total Hip Bone Mineral Density by DXA
|
-0.039 g/cm^2
Standard Deviation 0.041
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsEarly changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).
Outcome measures
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Change in Trabecular Spine Bone Mineral Density by QCT
|
4.9 mg/cm^3
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 6 monthsHypocalcemia, if detected, will be graded according to common terminology for adverse event criteria (CTCAE v.4). Adverse events considered related or possibly related are counted.
Outcome measures
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsEarly changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Change From Baseline of Femoral Neck Bone Density Measured by DXA
|
-0.038 g/cm^2
Standard Deviation 0.032
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsEarly changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Outcome measures
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 Participants
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Change From Baseline of Spine Bone Density Measured by DXA
|
0.003 g/cm^2
Standard Deviation 0.074
|
Adverse Events
Drug: Zoledronic Acid, Calcium+Vitamin D
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 participants at risk
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
Ear and labyrinth disorders
Vertigo
|
25.0%
1/4 • Number of events 1 • 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.
We used definitions consistent with CTCAE version 4.0
|
Other adverse events
| Measure |
Drug: Zoledronic Acid, Calcium+Vitamin D
n=4 participants at risk
Subjects will receive a single intravenous infusion of zoledronic acid (5 mg). Supplemental calcium citrate + vitamin D (500mg+500IU) and vitamin D3 (1000 IU) will be dispensed throughout the study to fit individual needs.
Ergocalciferol 50,000 international units once a day for three days administered prior to Zoledronic Acid
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy
|
|---|---|
|
General disorders
Fever and body aches
|
50.0%
2/4 • Number of events 2 • 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.
We used definitions consistent with CTCAE version 4.0
|
|
Gastrointestinal disorders
Diverticulitis flair
|
25.0%
1/4 • Number of events 1 • 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.
We used definitions consistent with CTCAE version 4.0
|
|
Gastrointestinal disorders
Post-op GI pain
|
25.0%
1/4 • Number of events 1 • 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.
We used definitions consistent with CTCAE version 4.0
|
|
Immune system disorders
pseudogout flair
|
25.0%
1/4 • Number of events 3 • 6 to 7 months, starting with pre-surgical drug administration and following until 24 weeks after surgery.
We used definitions consistent with CTCAE version 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place