Morbid obese subjects undergoing bariatric surgery
Conditions
Interventions
Trade Name: Aclasta
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Sponsors
Hospital South West Jutland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Eligible for bariatric surgery according to current Danish National Guidelines* • Women or men • 35 years or older *The National Danish Guideline for Bariatric Surgery currently includes either 1: BMI=50 kg/m2, 2: BMI=35 kg/m2 and an obesity related comorbid condition of type 2 diabetes, sleep apnea, arthrosis of the hip or knee, polycystic ovary syndrome with an unmet wish for pregnancy or treatment resistant hypertension or 3: BMI=40 kg/m2 with an obesity related health risk other than those specified in 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnancy or breastfeeding. • Chronic kidney disease with estimated GFR<45 ml/min. • Hypocalcemia defined as an ionized calcium <1.18 mmol/l. • Hypersensitivity to bisphosphonates, mannitol, sodium citrate or water. • Metabolic bone disease or treatment with anti-osteoporotic agents. • Current treatment with oral glucocorticoids or other drugs with effects on bone metabolism • Other diseases with known effects on bone metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of zoledronic acid on bone mineral density in patients after bariatric surgery., ;Secondary Objective: To evaluate the effects of zoledronic acid on bone structure and metabolism and muscle mass, strength and physical function in patients after bariatric surgery., ;Primary end point(s): Bone mineral density by DXA at the proximal femur ;Timepoint(s) of evaluation of this end point: 12, 24 and 36 months after bariatric surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? CT of lumbar spine and total hip (assessment of volumetric BMD and bone structure), ?high-resolution peripheral quantitative computed tomography (HR-pQCT) of radius and tibia (assessment of bone microarchitecture and estimated bone strength), ?biochemical markers of bone metabolism (bone remodeling markers CTX and P1NP) ?osteokines (sclerostin, osteocalcin, insulin-like growth factor 1, endothelial growth factor) ?microindentation of proximal tibia (assessment of bone stiffness) ;Timepoint(s) of evaluation of this end point: 12,24 and 36 months after bariatric surgery | — |
Countries
Denmark
Contacts
Public ContactDepartment of Medicine
Hospital South West Jutland
Outcome results
None listed