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

Primary Purpose

Osteoporosis

Status

Unknown status

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Alendronate

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mcgill University Health centerRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00346190

First Posted

June 27, 2006

Last Updated

April 11, 2007

Sponsor

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

Collaborators

Merck Frosst Canada Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00346190

Brief Title

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

Official Title

A Six Month Double-Blind, Placebo-Controlled Trial Followed by Six Month Open-Label Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Unknown status

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

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

Collaborators

Merck Frosst Canada Ltd.

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Alendronate

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Richard Kremer, MD PhD

Phone

514-934-1934

Ext

32857

First Name & Middle Initial & Last Name or Official Title & Degree

Giselle Charrette, RN CONc

Phone

514-934-1934

Ext

35718

giselle.charrette@muhc.mcgill.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Kremer, MD PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mcgill University Health center

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Kremer, MD PhD

Phone

514-934-1934

Ext

32857

First Name & Middle Initial & Last Name & Degree

Richard Kremer, MD PhD FRCP(c)

12. IPD Sharing Statement

Learn more about this trial

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

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