Longterm Osteopenia in Crohn's Disease Study: Comparing the affect of Calcium & Vitamin D or additional Sodium-Fluoride or Ibandronate on Bone Mineral Density and Fractures in Crohn’s Disease

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2010
INTERVENTION: Patients were randomised to treatment‐group A, B and C, taking study‐medication as follows: Group A: 10000 International Units (IU) colecalciferol (Vigantoletten®, Merck, Darmstadt/Germany) and 800mg calcium‐citrate (Calcitrat®, Merckle, Ulm/Germany) daily Group B: 1000IU colecalciferol and 800mg calcium‐citrate daily with an additional 25mg of slow‐release sodium‐fluoride (Nafril®, Merckle, Ulm/Germany) twice daily (bid) Group C: Basic colecalciferol and calcium with an additional 1mg/IV of ibandronate (Bondronat®, Roche, Basle/Switzerland) 3 times a month Follow‐up examinations were conducted at 3‐month intervals. In group B, sodium‐fluoride was taken daily for 12‐months, followed by a 3‐months fluoride‐free period. The 2nd and 3rd 12‐month cycle started at month 15 and 30. CONDITION: Crohn's disease, Osteoporosis ; Musculoskeletal Diseases ; Crohn's disease [regional enteritis] PRIMARY OUTCOME: Dual Energy X‐ray Absorptiometry (DEXA) of the lumbar spine and plain radiography of the spine performed at baseline and after 1.0, 2.25 and 3.5 years.; SECONDARY OUTCOME: Fracture rate (spine, T4‐L4) INCLUSION CRITERIA: 1. Crohn's disease 2. Reduced bone mineral density (T‐score < ‐1,0)
Epistemonikos ID: fe1c059ab1132e8214efff83dbe546f43b5c3f24
First added on: Aug 22, 2024