Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Osteopenie_01
Study information
Scientific title
A 3.5 year Randomised Controlled Study on Bone Mineral Density and Fractures in Crohns Disease comparing Calcium & Vitamin D or additional Sodium-Fluoride or Ibandronate
Acronym
Study hypothesis
To 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
The Ethics Committee of the University of Ulm, Germany approved on the 7th of April 1998 (ref: 281998)
Study design
3 arm randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Crohn's disease, Osteoporosis
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
Fracture rate (spine, T4-L4)
Overall trial start date
01/04/1998
Overall trial end date
30/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Crohn's disease
2. Reduced bone mineral density (T-score < -1,0)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. 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
Recruitment start date
01/04/1998
Recruitment end date
30/08/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Albert Einstein Allee 23
Ulm
89081
Germany
Sponsor information
Organisation
University Hospital Ulm (Universitätsklinikum Ulm) (Germany)
Sponsor details
Clinic for Internal Medicine I
(Klinik für Innere Medizin I)
Albert-Einstein-Allee 23
Ulm
89081
Germany
Sponsor type
University/education
Website
http://www.uniklinik-ulm.de/struktur/kliniken/innere-medizin/klinik-fuer-innere-medizin-i.html
Funders
Funder type
University/education
Funder name
University of Ulm (Germany) - Department of Internal Medicine I, Gastroenterology and Endocrinology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary