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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00346190
First received: June 27, 2006
Last updated: April 11, 2007
Last verified: January 2006
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: Alendronate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Estimated Enrollment: 10
Study Start Date: January 2003
Estimated Study Completion Date: April 2007
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346190

Contacts
Contact: Richard Kremer, MD PhD 514-934-1934 ext 32857
Contact: Giselle Charrette, RN CONc 514-934-1934 ext 35718 giselle.charrette@muhc.mcgill.ca

Locations
Canada, Quebec
Mcgill University Health center Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Richard Kremer, MD PhD     514-934-1934 ext 32857        
Principal Investigator: Richard Kremer, MD PhD FRCP(c)            
Sponsors and Collaborators
McGill University Health Center
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Richard Kremer, MD PhD McGill University Health Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346190     History of Changes
Other Study ID Numbers: CA-16
Study First Received: June 27, 2006
Last Updated: April 11, 2007
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Hip Fractures
Osteoporosis
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
 Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013