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

ISRCTN ISRCTN80829286
DOI https://doi.org/10.1186/ISRCTN80829286
Protocol serial number Osteopenie_01
Sponsor University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
Funder University of Ulm (Germany) - Department of Internal Medicine I, Gastroenterology and Endocrinology
Submission date
09/03/2010
Registration date
14/04/2010
Last edited
14/04/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jochen Klaus
Scientific

Albert Einstein Allee 23
Ulm
89081
Germany

Study information

Primary study designInterventional
Study design3 arm randomised active controlled parallel group trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA 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
Study objectivesTo assess the effect of colecalciferol and calcium administration alone or with additional sodium-fluoride or ibandronate on bone mineral density (BMD) and fracture rate in Crohn's disease patients with reduced bone mineral density
Ethics approval(s)The Ethics Committee of the University of Ulm, Germany approved on the 7th of April 1998 (ref: 281998)
Health condition(s) or problem(s) studiedCrohn's disease, Osteoporosis
InterventionPatients 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.
Intervention typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Fracture rate (spine, T4-L4)

Completion date30/08/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration200
Key inclusion criteria1. Crohn's disease
2. Reduced bone mineral density (T-score < -1,0)
Key exclusion criteria1. Age <18 years
2. Chronic renal insufficiency (creatinine >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
Date of first enrolment01/04/1998
Date of final enrolment30/08/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Albert Einstein Allee 23
Ulm
89081
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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