The Study of the Early Administration of Alendronate on P... | NCT00346190

Studies
The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

NCT00346190

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Status

Unknown status

Last Update Posted

Apr 12, 2007Estimated

Enrollment

Phase

Phase 3

Conditions

Osteoporosis

Interventions

Alendronate

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

Status Module

Record Verification Date

Jan 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2003

Primary Completion Date

Not provided

Completion Date

Apr 2007Estimated

First Submitted Date

Jun 27, 2006

First Submission Date that Met QC Criteria

Jun 27, 2006

First Posted Date

Jun 29, 2006Estimated

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

Apr 11, 2007

Last Update Posted Date

Apr 12, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER

Collaborators

Name	Class
Merck Frosst Canada Ltd.	INDUSTRY

Description Module

Brief Summary

To determine whether administration of Alendronate early is more effective than late in the prevention of osteoporosis following a hip fracture

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

Name	Type	Description	Arm Group Labels	Other Names
Alendronate	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and Female aged > 55 Low trauma hip fracture up to 90 days Be willing to submit to periodic bone mineral density radiographic studies of the spine & 24 hr urine collection Written informed consent

Exclusion Criteria:

Disorders known to affect bone metabolism Not taking bisphosphonates within last 6 months Drugs known to interfere with calcium metabolism within the lats 6 months prior to hip fracture serum calcium> 2.65 mmol/L Treatment with any investigational drug within the last 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Richard Kremer, MD PhD	Contact	514-934-1934	32857
Giselle Charrette, RN CONc	Contact	514-934-1934	35718	giselle.charrette@muhc.mcgill.ca

Overall Officials

Name	Affiliation	Role
Richard Kremer, MD PhD	McGill University Health Centre/Research Institute of the McGill University Health Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mcgill University Health center	Recruiting	Montreal	Quebec	H3A 1A1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010024	Osteoporosis

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
D019386	Alendronate

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided