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

This study is currently recruiting participants.

Verified by McGill University Health Center, January 2006

Sponsors and Collaborators:	McGill University Health Center Merck Frosst Canada Ltd.
Information provided by:	McGill University Health Center
ClinicalTrials.gov Identifier:	NCT00346190

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 III

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Osteoporosis

Drug Information available for: Alendronate Alendronate sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

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

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

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Musculoskeletal Diseases
Alendronate
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Osteoporosis
Bone Diseases, Metabolic
Leg Injuries
Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs
Bone Density Conservation Agents
Hip Injuries
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009