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

Sponsor

University of Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT01215890

Collaborator

(none)

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Low Bone Mineral Density	Drug: risedronate Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

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

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: risedronate plus calcium and viamin D	Drug: risedronate
Placebo Comparator: placebo plus clacium and vitamin D	Drug: placebo

Arm

Intervention/Treatment

Active Comparator: risedronate plus calcium and viamin D

Drug: risedronate

Placebo Comparator: placebo plus clacium and vitamin D

Drug: placebo

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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