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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Zoledronic Acid, Calcium+Vitamin D | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | 5mg zoledronic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 6 months |
| Change in Trabecular Spine Bone Mineral Density by QCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine W Yu, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ng/ml | Baseline and 6 months |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | CTCAE 4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever and body aches | General disorders | CTCAE 4.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elaine Yu | Massachusetts General Hospital | 617-643-6353 | ewyu@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2019 | Mar 2, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2018 | Apr 2, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| D019355 | Calcium Citrate |
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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All of the participants will receive zoledronic acid, as well as supplementation with calcium and vitamin D.
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| Calcium citrate + vitamin D | Dietary Supplement | Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3 |
|
| Vitamin D3 | Dietary Supplement | 1000IU Vitamin D3 gummy |
|
Early changes in volumetric bone mineral density will be measured at the spine by Quantitative Computed Tomography (QCT). |
| Baseline and 6 months |
| 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. | 6 months |
| 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). | Baseline and 6 months |
| 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). | Baseline and 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | lb |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Subtotal body fat | Mean | Standard Deviation | kg |
|
| Subtotal body lean mass | Mean | Standard Deviation | kg |
|
| Serum calcium | Mean | Standard Deviation | mg/dl |
|
| Serum creatinine | Mean | Standard Deviation | mg/dl |
|
| Serum 25-hydroxyvitamin D | Mean | Standard Deviation | ng/ml |
|
| Serum parathyroid hormone (PTH) | Mean | Standard Deviation | pg/ml |
|
| Serum CTX | Mean | Standard Deviation | ng/ml |
|
| Serum Procollagen 1 Intact N-Terminal Propeptide (P1NP) | Mean | Standard Deviation | ug/l |
|
| DXA Spine areal bone mineral density (aBMD) | Mean | Standard Deviation | g/cm^2 |
|
| DXA Femoral neck aBMD | Mean | Standard Deviation | g/cm^2 |
|
| DXA Total hip aBMD | Mean | Standard Deviation | g/cm^2 |
|
| QCT Trabecular spine volumetric bone mineral density (vBMD) | Mean | Standard Deviation | mg/cm^3 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | Posted | Mean | Standard Deviation | g/cm^2 | Baseline and 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | mg/cm^3 | Baseline and 6 months |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | g/cm^2 | Baseline and 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | g/cm^2 | Baseline and 6 months |
|
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| 3 |
| 4 |
| Diverticulitis flair | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| Post-op GI pain | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
|
| pseudogout flair | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
|
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| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |