NCT00138866

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2004

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

October 13, 2010

Status Verified

July 1, 2008

Enrollment Period

4.2 years

First QC Date

August 29, 2005

Last Update Submit

October 12, 2010

Conditions

Osteoporosis

Keywords

Spinal cord injury

Outcome Measures

Primary Outcomes (1)

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

    18 months

Secondary Outcomes (3)

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

    18 months

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

    18 months

  • The frequency and severity of adverse events

    18 months

Interventions

RisedronateDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehab, Lyndhurst Centre

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

OsteoporosisSpinal Cord Injuries

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • B. Cathy Craven, MD, FRCPC

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

November 1, 2004

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

October 13, 2010

Record last verified: 2008-07

Locations

CA(1)