Bariatric Surgery Candidate
Conditions
Keywords
Roux-en-Y gastric bypass, sleeve gastrectomy
Brief summary
This study evaluates whether zoledronic acid can prevent the high bone turnover that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.
Detailed description
The investigators are evaluating the ability of a single dose of zoledronic acid to improve bone outcomes after RYGB or SG surgery. The investigators have previously shown that RYGB and SG have negative effects on bone density, bone microarchitecture, and that bariatric procedures potentially increase the risk of fractures. The purpose of this study is to evaluate the safety and efficacy of zoledronic acid to prevent the high-turnover bone loss that occurs in adults who have chosen to undergo RYGB or SG.
Interventions
DRUGZoledronic Acid
5mg zoledronic acid
DIETARY_SUPPLEMENTCalcium citrate + vitamin D
Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
DIETARY_SUPPLEMENTVitamin D3
1000IU Vitamin D3 gummy
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
Eligibility
Sex/Gender
ALL
Age
25 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Men must be age ≥ 50 * Women must be age ≥ 25 and postmenopausal * Planning to receive RYGB or SG surgery
Exclusion criteria
* Age \< 25 * Prior bariatric surgery * Weight ≥ 400 lbs * Liver or renal disease * Hypercalcemia, hypocalcemia, or hypomagnesemia * Serum 25-hydroxyvitamin D \< 20 ng/mL * History of bone-modifying disorders * Use of bone-active medications * Known sensitivity to bisphosphonates * Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum CTX | Baseline and 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Hip Bone Mineral Density by DXA | Baseline and 6 months | Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA). |
| Change in Trabecular Spine Bone Mineral Density by QCT | Baseline and 6 months | Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT). |
| Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0 | 6 months | Hypocalcemia, 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. |
| Change From Baseline of Femoral Neck Bone Density Measured by DXA | Baseline and 6 months | Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA). |
| Change From Baseline of Spine Bone Density Measured by DXA | Baseline and 6 months | Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Zoledronic Acid: 5mg zoledronic acid
Calcium citrate + vitamin D: Chewable 500mg calcium citrate with 500IU Vitamin D3
Vitamin D3: 1000IU Vitamin D3 gummy | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Drug: Zoledronic Acid, Calcium+Vitamin D |
|---|---|
| Age, Continuous | 56.0 years STANDARD_DEVIATION 10 |
| BMI | 40.9 kg/m^2 STANDARD_DEVIATION 2 |
| DXA Femoral neck aBMD | 0.811 g/cm^2 STANDARD_DEVIATION 0.124 |
| DXA Spine areal bone mineral density (aBMD) | 1.065 g/cm^2 STANDARD_DEVIATION 0.095 |
| DXA Total hip aBMD | 0.953 g/cm^2 STANDARD_DEVIATION 0.124 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| QCT Trabecular spine volumetric bone mineral density (vBMD) | 114 mg/cm^3 STANDARD_DEVIATION 41 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Serum 25-hydroxyvitamin D | 39.8 ng/ml STANDARD_DEVIATION 14.8 |
| Serum calcium | 9.4 mg/dl STANDARD_DEVIATION 0.3 |
| Serum creatinine | 0.72 mg/dl STANDARD_DEVIATION 0.14 |
| Serum CTX | 0.226 ng/ml STANDARD_DEVIATION 0.163 |
| Serum parathyroid hormone (PTH) | 43.5 pg/ml STANDARD_DEVIATION 20.6 |
| Serum Procollagen 1 Intact N-Terminal Propeptide (P1NP) | 35.6 ug/l STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 0 Participants |
| Subtotal body fat | 46.9 kg STANDARD_DEVIATION 4.2 |
| Subtotal body lean mass | 49.8 kg STANDARD_DEVIATION 5.8 |
| Weight | 226.0 lb STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 3 / 4 |
| serious Total, serious adverse events | 1 / 4 |
Outcome results
Primary
Change in Serum CTX
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Change in Serum CTX | 0.228 ng/ml | Standard Deviation 0.117 |
Secondary
Change From Baseline of Femoral Neck Bone Density Measured by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Change From Baseline of Femoral Neck Bone Density Measured by DXA | -0.038 g/cm^2 | Standard Deviation 0.032 |
Secondary
Change From Baseline of Spine Bone Density Measured by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Change From Baseline of Spine Bone Density Measured by DXA | 0.003 g/cm^2 | Standard Deviation 0.074 |
Secondary
Change in Total Hip Bone Mineral Density by DXA
Early changes in areal bone mineral density will be measured at the hip and spine by Dual-energy X-ray Absorptiometry (DXA).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Change in Total Hip Bone Mineral Density by DXA | -0.039 g/cm^2 | Standard Deviation 0.041 |
Secondary
Change in Trabecular Spine Bone Mineral Density by QCT
Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT).
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Change in Trabecular Spine Bone Mineral Density by QCT | 4.9 mg/cm^3 | Standard Deviation 7.8 |
Secondary
Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0
Hypocalcemia, 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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Number of Participants With Treatment-related Hypocalcemia Events as Assessed by CTCAE v4.0 | 0 Participants |