Condition category
Musculoskeletal Diseases
Date applied
09/03/2010
Date assigned
14/04/2010
Last edited
14/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jochen Klaus

ORCID ID

Contact details

Albert Einstein Allee 23
Ulm
89081
Germany

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 Crohn’s 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

Publication citations

Additional files

Editorial Notes