Table 1.
Inclusion and exclusion criteria.
| Criteria | Inclusion Criteria | Exclusion Criteria |
|---|---|---|
| Written Consent | Sign and agree | Do not sign/agree |
| Age (years) | ≥40 | <40 |
| Obesity Stats | BMI ≥40 kg/m2 or BMI ≥35 kg/m2 | Weight >450 lbs [204 kg] (DXA/CT limit) |
| with ≥1 obesity related complication including: | ||
| Hypertension (>160/90 mm Hg); | ||
| Type II diabetes; Hyperlipidemia; Obstructive Sleep Apnea | ||
| Allergy | Known allergy to bisphosphonates | |
| Surgical Status | Cleared by attending physician for SG procedure | |
| Transportation | Able and willing to provide own transportation to screening and assessment visits | |
| Blood Markers | Serum calcium (8.6–10.2 mg/dL) | Serum calcium outside of normal range |
| PTH (15–65 pg/mL) | PTH outside of normal range | |
| eGFR ≥45 mL/min/1.73 m [2] | eGFR <45 mL/min/1.73 m [2] | |
| 25-hydroxyvitamin D levels ≥20 ng/mL | 25-hydroxyvitamin D levels <20 ng/mL | |
| Mobility | Dependent on cane/walker | |
| Medication use | Current or prior (within the past year) use of growth hormones; oral steroids for more than 6 consecutive days in the past 6 months or any use of prescription osteoporosis medications | |
| Unstable gastric reflux requiring two or more additional doses per month of anti-reflux medication | ||
| Research participation | Participation in another conflicting research study | |
| Unable to position on DXA or CT scanner independently | ||
| Medical Contraindications | Existing osteoporosis; Planned hip surgery or existing bilateral hip implants; Pregnancy or potential pregnancy (positive pregnancy test or unwilling to use a highly effective contraception method during active study phase); Esophageal abnormalities; Increased risk of ulceration; Paget's disease; Primary hyperparathyroidism; Hyper/hypothyroidism; Severe liver disease; History of malignancy within 5 years; Use of bone-active medications; Sensitivity to bisphosphonates; Extensive dental work involving extraction or dental implant within the past 2 months or planned upcoming 6 months; Existing risk of osteonecrosis of the jaw or atypical femur fracture; Deemed unfit for any reason by study physician/principal investigator |
BMI: Body Mass Index; kg: Kilogram; lb: Pound; DXA: Dual-Energy X-Ray Absorptiometry; CT: Computed Tomography; mm HG: millimeters mercury; SG: Sleeve Gastrectomy; mg: milligram; dL: Deciliter; PTH: Parathyroid Hormone; pg: picogram; eGFR: Estimated Glomerular Filtration Rate; min: minute; m: meters; ng: nanogram.