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

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ClinicalTrials.gov Identifier: NCT00346190
Recruitment Status : Unknown
Verified January 2006 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : June 29, 2006
Last Update Posted : April 12, 2007
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by:
McGill University Health Center

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Alendronate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : January 2003
Estimated Study Completion Date : April 2007

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00346190     History of Changes
Other Study ID Numbers: CA-16
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: April 12, 2007
Last Verified: January 2006

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