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Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease

Primary Purpose

Crohn's Disease, Low Bone Mineral Density

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
risedronate
placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Crohn's Disease focused on measuring Crohn's disease, Low bone mineral density, inflammatory bowel disease, bisphosphonate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

  • Patients who had received:

    1. previous bisphosphonate therapy
    2. fluoride supplement in the 24 months prior to entry
    3. calcium supplements of more than 1.0g/day in the 6 months prior to entry
    4. vitamin D supplements greater than 1000 IU/day in the 6 months prior to entry
    5. 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

Sites / Locations

  • Gastrointestinal and Liver Disease Research (GILDR) Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

risedronate plus calcium and viamin D

placebo plus clacium and vitamin D

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 5, 2010
Last Updated
October 5, 2010
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT01215890
Brief Title
Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Alberta

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Low Bone Mineral Density
Keywords
Crohn's disease, Low bone mineral density, inflammatory bowel disease, bisphosphonate

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
risedronate plus calcium and viamin D
Arm Type
Active Comparator
Arm Title
placebo plus clacium and vitamin D
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Type
Drug
Intervention Name(s)
placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Fedorak, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal and Liver Disease Research (GILDR) Group
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G-2X8
Country
Canada

12. IPD Sharing Statement

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Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease

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