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

A 3.5 year Randomised Controlled Study on Bone Mineral Density and Fractures in Crohn?s Disease comparing Calcium & Vitamin D or additional Sodium-Fluoride or Ibandronate

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN80829286

Enrollment

200

Registered

2010-04-14

Start date

1998-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease, Osteoporosis Musculoskeletal Diseases Crohn's disease [regional enteritis]

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Crohn's disease 2. Reduced bone mineral density (T-score < -1,0)

Exclusion criteria

Exclusion criteria: 1. Age 1,5mg/dl) 3. Known primary hypo- or hyperparathyroidism 4. Untreated thyroid disease 5. Any known medication, e.g. previous treatment with either sodium-fluoride or bisphosphonates 6. Condition affecting BMD other than glucocorticoids

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Fracture rate (spine, T4-L4)	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026