Condition category
Digestive System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
02/03/2007
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

Mr Maartje de Ley

ORCID ID

Contact details

IBD trial bureau
C2-317
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 6545
m.deley@compaqnet.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Crohn and Bone study

Study hypothesis

Bifosfornates in combination with vitamin D and Calcium is more effective that Vitamin D and Calcium alone for Crohn’s disease related osteopenia.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo controlled, parallel group, double blinded multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Crohn's, Osteopenia

Intervention

For both study groups: 1000 mg Calcium and 400 IU vitamin D.
Group I: weekly 35 mg risedronate (Actonel®)
Group II: weekly one placebo tablet

Patients will receive treatment for 24 months.

Intervention type

Supplement

Phase

Not Specified

Drug names

Calcium, vitamin D and risedronate (Actonel®)

Primary outcome measures

The primary objective of this study is to determine the change in BMD, expressed as T-score, at lumbar spine and total hip as assessed by DEXA after 24 months of treatment with Calcium 1 g and vitamin D3 400 IU once daily (o.d.), with concomitant weekly 35 mg risedronate (Actonel®) compared to placebo in patients suffering from Crohn’s disease.

Secondary outcome measures

1. To study the histomorphometric, micro architectural and mineralisation changes in bone after treatment of bone loss in patients with Crohn’s disease with calcium and vitamin D alone or in combination with risedronate
2. To determine changes in markers of bone metabolism (bone specific alkaline phosphatase, osteocalcine, and type-one collagen C-telopeptide)
3. To establish the incidence of non-vertebral and vertebral fractures, as measured by semi-quantitative assessment of digital, standardised radiographs of the spine

Overall trial start date

30/08/2004

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women between 18 and 70 years of age
2. Patients suffering from Crohn's disease of at least three months duration, confirmed by radiography, endoscopy and histology
3. Quiescent stage of disease as defined by the Crohn's Disease Activity Index (CDAI less than 150)
4. A Bone Mineral Density (BMD) between -1.0 SD and -2.5 SD as assessed by Dual Energy X-ray Absorptiometry (DEXA) (T-score) of lumbar spine or total hip
5. A serum 25(OH)-vitamin D level more than 25 nmol/L
6. Patients must be able to adhere to the study visit schedule and protocol requirements
7. Patients must be able to give informed consent and the consent must be obtained prior to any study procedures

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

130

Participant exclusion criteria

1. Patients with a DEXA T-score less than -25 in lumbar spine or total hip
2. Patients who have received bisphosphonates a year prior to inclusion, or who are known with an allergy to bisphosphonates
3. Patients who have received calcitonin or suppressive doses of thyroxine within one year
4. Patients with serum 25(OH)-vitamin D levels less than 25 nmol/L (supplementation for three months prior to (renewed) screening is allowed)
5. Corticosteroid treatment three months prior to screening or during the screening phase with daily dosages above 75 mg prednisole-equivalent at any time
6. A history of hyperthyroidism, Paget's disease or other metabolic bone diseases, Cushing's disease or hyperprolactinemia
7. Female patients who are pregnant or breast-feeding
8. Patients receiving hormonal replacement therapy
9. A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study

Recruitment start date

30/08/2004

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

IBD trial bureau
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Aventis (The Netherlands)

Sponsor details

P.O. Box 2043
Gouda
2800 BD
Netherlands
+31 (0)182 557 696
info.nl@aventis.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Aventis (The Netherlands)

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