Risedronate for the Prevention of Osteoporosis in People... | NCT00150696

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

NCT00150696

Sponsor

Toronto Rehabilitation Institute

Status

Completed

Last Update Posted

Nov 21, 2007Estimated

Enrollment

Phase

Phase 3

Conditions

Acute Spinal Cord Injury.

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
ONRO-79

Status Module

Record Verification Date

Nov 2007

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

Feb 2000

Primary Completion Date

Not provided

Completion Date

Nov 2005

First Submitted Date

Sep 6, 2005

First Submission Date that Met QC Criteria

Sep 6, 2005

First Posted Date

Sep 8, 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

Nov 20, 2007

Last Update Posted Date

Nov 21, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Toronto Rehabilitation InstituteOTHER

Collaborators

Name	Class
Ontario Neurotrauma Foundation	OTHER
St. Joseph's Healthcare Foundation	OTHER
Queen Elizabeth Hospital NHS Foundation Trust	OTHER

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

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 and proximal tibia between baseline, 12-months and 24-months.

Secondary Outcomes

Measure	Description	Time Frame
Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.
Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

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
Hamilton Health Sciences, Chedoke Site		Hamilton	Ontario	L8N 3Z5	Canada
Toronto Rehab, Lyndhurst Centre

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