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Completed

NCT Number: NCT00150696

Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.

The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.

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Key information

Conditions

Acute Spinal Cord Injury. Bone Diseases Bone Diseases, Metabolic Central Nervous System Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Osteoporosis Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences, Chedoke Site, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Traumatic spinal cord injury less than 100 days.
  • Must be able to swallow tablets and sit upright.

Exclusion criteria

  • Bilateral knee flexion contractures.
  • Pregnant, lactating or post-menopausal females.
  • Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis.
  • Treatment in the last year with calcitonin, fluoride or anabolic steroid.
  • Concurrent treatment with prednisone.

Treatment and study plan

risedronate

Drug

Primary outcomes

  1. Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.

Secondary outcomes

  1. Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.

  2. Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.

  3. Frequency and severity of adverse events.

  4. Quality of life.

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Ontario Neurotrauma Foundation
  • Queen Elizabeth Hospital NHS Foundation Trust
  • St. Joseph's Healthcare Foundation

Registry information

Official study title

Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Important dates

Study start
2000
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Nov 21, 2007

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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