Zoledronic acid for prevention of bone loss after bariatric surgery

Phase 1

• Conditions: Morbid obese subjects undergoing bariatric surgery; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-001650-26-DK
• Lead Sponsor: Hospital South West Jutland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified