EUCTR2019-001650-26-DK
Active, not recruiting
Phase 1
Zoledronic acid for prevention of bone loss after bariatric surgery
Hospital South West Jutland0 sites70 target enrollmentSeptember 10, 2019
ConditionsMorbid obese subjects undergoing bariatric surgeryTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsAclasta
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Morbid obese subjects undergoing bariatric surgery
- Sponsor
- Hospital South West Jutland
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 70
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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
Outcomes
Primary Outcomes
Not specified
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