Treatment of bone loss and changes in bone architecture in osteopenic patients with Crohn's disease: a comparison between calcium supplementation and vitamin D alone or combined with oral risedronate 35 mg once weekly

ISRCTN	ISRCTN59682218
DOI	https://doi.org/10.1186/ISRCTN59682218
Protocol serial number	N/A
Sponsor	Aventis (The Netherlands)
Funder	Aventis (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 20/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Maartje de Ley
Scientific

IBD trial bureau
C2-317
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 6545
Email	m.deley@compaqnet.nl

Study information

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded multicentre trial
Secondary study design	Randomised controlled trial
Scientific title	Treatment of bone loss and changes in bone architecture in osteopenic patients with Crohn's disease: a comparison between calcium supplementation and vitamin D alone or combined with oral risedronate 35 mg once weekly
Study acronym	Crohn and Bone study
Study objectives	Bifosfornates in combination with vitamin D and Calcium is more effective that Vitamin D and Calcium alone for Crohns disease related osteopenia.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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 Crohns disease.
Key secondary outcome measure(s)	1. To study the histomorphometric, micro architectural and mineralisation changes in bone after treatment of bone loss in patients with Crohns 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
Completion date	31/08/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	130
Key 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
Key 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
Date of first enrolment	30/08/2004
Date of final enrolment	31/08/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

IBD trial bureau

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/10/2013	20/08/2021	Yes	No

Editorial Notes

20/08/2021: Publication reference added.