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Completed

NCT Number: NCT00138866

Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury

The purpose of this study is to find out if risedronate works for the treatment of osteoporosis for people with spinal cord injury.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Traumatic spinal cord injury of greater than 18 months
  • Osteopenia or osteoporosis of the hip
  • Must be able to swallow tablets and sit upright

Exclusion criteria

  • Bilateral heterotopic ossification
  • Bilateral lower extremity metal implants
  • Pregnant or lactating females
  • Paget's disease
  • Osteomalacia
  • Steroid induced bone loss
  • Untreated parathyroid or thyroid disease
  • Symptomatic hypocalcemia or hypophosphatemia
  • Treatment in the last year with calcitonin, fluoride or anabolic steroids
  • Current treatment with prednisone

Treatment and study plan

risedronate

Drug

Primary outcomes

  1. Change in bone mineral density of the distal femur between baseline and 18-months

    Time frame: 18 months

Secondary outcomes

  1. Change in bone mineral density of the hips and proximal tibia between baseline and 18-months

    Time frame: 18 months

  2. The change in biochemical bone markers of bone turnover between baseline and 18-months

    Time frame: 18 months

  3. The frequency and severity of adverse events

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • St. Joseph's Health Care London
  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Risedronate for Treatment of Sublesional Osteoporosis After Spinal Cord Injury

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Aug 30, 2005
Registry last updated
Oct 13, 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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