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OpenTrials
Completed

NCT Number: NCT01215890

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gastrointestinal and Liver Disease Research (GILDR) Group

Edmonton, Alberta, T6G-2X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

Drug

Placebo

Drug

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study 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

Important dates

First posted
Oct 7, 2010
Registry last updated
Oct 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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