The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
Information source: McGill University Health Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Alendronate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: McGill University Health Center Official(s) and/or principal investigator(s):
Richard Kremer, MD PhD, Principal Investigator, Affiliation: McGill University Health Center
Overall contact:
Richard Kremer, MD PhD, Phone: 514-934-1934, Ext: 32857
Summary
To determine whether administration of Alendronate early is more effective than late in the
prevention of osteoporosis following a hip fracture
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
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
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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
Locations and Contacts
Richard Kremer, MD PhD, Phone: 514-934-1934, Ext: 32857
Mcgill University Health center, Montreal, Quebec H3A 1A1, Canada; Recruiting
Richard Kremer, MD PhD, Phone: 514-934-1934, Ext: 32857
Richard Kremer, MD PhD FRCP(c), Principal Investigator
Additional Information
Starting date: January 2003
Last updated: April 11, 2007
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