Condition category
Digestive System
Date applied
16/11/2008
Date assigned
20/11/2008
Last edited
06/10/2011
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

Prof Jonathan H Tobias

ORCID ID

Contact details

Academic Rheumatology
Avon Orthopaedic Centre
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Additional identifiers

EudraCT number

2004-004325-10

ClinicalTrials.gov number

Protocol/serial number

ME/2005/2018; 2004-004325-10

Study information

Scientific title

A randomised controlled trial to evaluate whether a short course of once weekly risedronate prevents bone loss following high-dose steroid therapy for an acute exacerbation of inflammatory bowel disease

Acronym

Study hypothesis

The hypothesis is based on the observation that osteoporosis occurs in patients with inflammatory bowel disease (IBD) and that detectable bone loss occurs after steroid treatment for only 8 weeks. Bisphosphonates are effective at treating bone loss but whether it is effective at preventing bone loss in this context is being addressed in this trial.

Ethics approval

Gloucestershire Research Ethics Committee approved the trial in June 2005 (ref: 05/Q2005/74)

Study design

Radonmised, double-blind, placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Inflammatory bowel disease (ulcerative colitis and Crohn's disease)

Intervention

All patients participating in the trial were given calcium and vitamin in the form of Cacit D3 effervescent granules (calcium 500 mg/Vitamin D 440IU) at a dose of one sachet daily. Patients were randomised to risedronate 35 mg weekly or a placebo.

The total duration of intervention was 8 weeks and follow up was for the same 8 weeks in both arms. Participants were seen at baseline and then 8 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Risedronate

Primary outcome measures

The difference in percentage change in total hip (and sub-regions of the hip) and lumbar spine bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) 8 weeks apart between treatment groups (baseline is when corticosteroids start and week 8 at completion of the steroids).

Secondary outcome measures

1. Do patients with ulcerative colitis and Crohn's disease have a differential response to steroid therapy or risedronate?
2. Change in markers of bone turnover (CTX for resorption and P1NP for formation) measured before steroids start (week -1), baseline and at week 8
3. Urinary steroid metabolites and cytokines measured from samples obtained at week -1

Overall trial start date

01/10/2005

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than or equal to 16 years, either sex
2. Ulcerative colitis and Crohn's disease
3. Experiencing a relapse
4. Requiring steroid therapy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Aged under 16 years
2. Use of corticosteroids in the preceding 3 months
3. Evidence of osteoporosis (known vertebral fracture, T score less than -2.5)
4. Pregnant and lactating women
5. Women of childbearing age will be eligible provided they use reliable contraception
6. Bone active therapy within previous 12 months (excluding calcium and low dose vitamin D)
7. Previous treatment with a bisphosphonate at any time
8. Associated disorder which may influence bone metabolism
9. Lactose intolerance

Recruitment start date

01/10/2005

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Rheumatology
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

University Hospitals Bristol NHS Foundation Trust (UK)

Sponsor details

c/o Dr Maria Palmer
Director of Research and Effectiveness Department
Bristol Royal Infirmary
Bristol
BS2 8HW
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Procter and Gamble Pharmaceuticals (UK) - educational grant.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The funder had no input into the study design, recruitment or the analysis of the results.

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19484170

Publication citations

  1. Results

    Kriel MH, Tobias JH, Creed TJ, Lockett M, Linehan J, Bell A, Przemioslo R, Smithson JE, Brooklyn TN, Fraser WD, Probert CS, Use of risedronate to prevent bone loss following a single course of glucocorticoids: findings from a proof-of-concept study in inflammatory bowel disease., Osteoporos Int, 2010, 21, 3, 507-513, doi: 10.1007/s00198-009-0960-8.

Additional files

Editorial Notes