The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
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.
1 other identifier
interventional
10
1 country
1
Brief Summary
To determine whether administration of Alendronate early is more effective than late in the prevention of osteoporosis following a hip fracture
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2003
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedApril 12, 2007
January 1, 2006
June 27, 2006
April 11, 2007
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mcgill University Health center
Montreal, Quebec, H3A 1A1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Kremer, MD PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 29, 2006
Study Start
January 1, 2003
Study Completion
April 1, 2007
Last Updated
April 12, 2007
Record last verified: 2006-01