Risedronate for the Treatment of Osteoporosis for People... | NCT00138866

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

NCT00138866

Sponsor

Toronto Rehabilitation Institute

Status

Completed

Last Update Posted

Oct 13, 2010Estimated

Enrollment

46Estimated

Phase

Phase 3

Conditions

Osteoporosis

Interventions

Risedronate

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PSI #03-52

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Jan 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2010

Last Update Posted Date

Oct 13, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Toronto Rehabilitation InstituteOTHER

Collaborators

Name	Class
The Physicians' Services Incorporated Foundation	OTHER
St. Joseph's Health Care London	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Name	Type	Description	Arm Group Labels	Other Names
Risedronate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in bone mineral density of the distal femur between baseline and 18-months		18 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
B. Cathy Craven, MD, FRCPC	Toronto Rehabilitation Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Rehab, Lyndhurst Centre		Toronto	Ontario	M4G 3V9	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068296	Risedronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided