Crohn's DiseasePhase 4NCT01215890
Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease
A Phase 4 study testing risedronate in people with Crohn's Disease and Low Bone Mineral Density, run by University of Alberta at 1 site in Canada.
Trial summary
The occurrence of bone loss in Crohn's disease patients is an important clinical problem for both patients with and without active disease. While therapy does exist for treatment and prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Low Bone Mineral Density
- What is being tested?
- risedronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are 18 years of age, or older.
- Crohn's disease, as documented by clinical, radiologic, endoscopic or histologic examination.
- Osteoporosis (T score less than -2.5) or osteopenia (T score between -1.0 and -2.5), as determined by dual energy X-ray absorptiometry.
Who cannot join
- Known bone disorders other than osteoporosis (such as hyperparathyroidism, Paget's disease, renal osteodystrophy and documented osteomalacia)
- Abnormal thyroid function. Those patients on thyroxine replacement must not have had a change in dose in the two months prior to prospective data collection program entry
- Clinically significant renal impairment (serum creatinine ≥ 2x normal).
- Clinical Short Bowel Syndrome
- Patients on total parenteral or enteral nutrition
- Spinal anatomy that would not allow adequate assessment of lateral spine using DEXA
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- Patients who had received:
- previous bisphosphonate therapy
- fluoride supplement in the 24 months prior to entry
- calcium supplements of more than 1.0g/day in the 6 months prior to entry
- vitamin D supplements greater than 1000 IU/day in the 6 months prior to entry
- calcitonin in the 3 months prior to entry
- Females on hormone replacement therapy who do not agree to continue the therapy for the duration of the prospective data collection program
- Men on testosterone who do not agree to continue it for the duration of the prospective data collection program
- Pregnancy or women who are breastfeeding
Trial locations and contacts
1 site in 1 country.
Canada1 site
Gastrointestinal and Liver Disease Research (GILDR) Group
Edmonton, Alberta, T6G-2X8
About this study
Official title: A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients
The occurrence of bone loss in Crohn's disease patients is an important clinical problem for both patients with and without active disease. While therapy does exist for treatment and prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with adequate calcium and vitamin D supplementation.
The primary objective of the study is to assess the efficacy of risedronate, compared to placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.
- Conditions
- Crohn's Disease, Low Bone Mineral Density
- Being tested
- risedronate, placebo
- Keywords
- Crohn's disease, Low bone mineral density, inflammatory bowel disease, bisphosphonate
- Medical subject headings
- Crohn Disease, Bone Diseases, Metabolic, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| risedronate plus calcium and viamin D | Active comparator | Not described Receives: Drug: risedronate |
| placebo plus clacium and vitamin D | Placebo comparator | Not described Receives: Drug: placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Investigators
- Richard Fedorak, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215890
- Sponsor's protocol ID
- RIS-RF
- Status last verified
- Oct 2010
- First submitted
- 5 Oct 2010
- Last updated
- 7 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT01215890
- Acronym / sponsor ID
- RIS-RF
- Conditions
- Crohn's Disease, Low Bone Mineral Density
- Keywords
- Crohn's disease, Low bone mineral density, inflammatory bowel disease, bisphosphonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- First posted
- 7 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The occurrence of bone loss in Crohn's disease patients is an important clinical problem for both patients with and without active disease. While therapy does exist for treatment and prevention of low BMD, evidence of its efficacy in Crohn's disease patients is lacking. The current standard of therapy in Canada for the treatment of osteoporosis is etidronate, with adequate calcium and vitamin D supplementation.
The primary objective of the study is to assess the efficacy of risedronate, compared to placebo, administered once-weekly, in the treatment of low BMD of the spine and hip in patients with Crohn's disease at 12 months, based on an intention-to-treat analysis.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| risedronate plus calcium and viamin D | Active comparator | Drug: risedronate |
| placebo plus clacium and vitamin D | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are 18 years of age, or older.
- Crohn's disease, as documented by clinical, radiologic, endoscopic or histologic examination.
- Osteoporosis (T score less than -2.5) or osteopenia (T score between -1.0 and -2.5), as determined by dual energy X-ray absorptiometry.
Key exclusion criteria (15 listed)
- Known bone disorders other than osteoporosis (such as hyperparathyroidism, Paget's disease, renal osteodystrophy and documented osteomalacia)
- Abnormal thyroid function. Those patients on thyroxine replacement must not have had a change in dose in the two months prior to prospective data collection program entry
- Clinically significant renal impairment (serum creatinine ≥ 2x normal).
- Clinical Short Bowel Syndrome
- Patients on total parenteral or enteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| risedronate | Drug | risedronate plus calcium and viamin D |
| placebo | Drug | placebo plus clacium and vitamin D |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Fedorak, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risedronate in people with Crohn's Disease and Low Bone Mineral Density, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2010.