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Completed

NCT Number: NCT00136058

Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

The objective of this study is to determine if an intervention with a fracture manager to arrange bone densitometry after a hip fracture is more effective in diagnosing and treating osteoporosis when compared to "usual care". "Usual care" consists of no intervention to arrange bone mineral density (BMD) testing or therapy other than what normally occurs in the community. The investigators postulate that a fracture manager will be more effective in getting BMD done and in starting appropriate therapy.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta

Edmonton, Alberta, T6G2S2, Canada

About this study

All hip fracture patients in the Edmonton area will be screened for eligibility (mini-mental status >20, not on active osteoporosis pharmacologic therapy). All patients will have informed consent obtained. Patients will be randomized to 2 groups:

  • Group 1: Active intervention. The fracture manager will arrange for bone densitometry (DEXA) to be done 3-6 months after the fracture. If the patient meets standard criteria for osteoporosis, therapy with a bisphosphonate (alendronate or risedronate) will be instituted by the study physicians.
  • Group 2: Usual care. Patients will receive basic information about calcium and vitamin D and osteoporosis and told to follow up with their family doctor. At 6 months, patients will be contacted to determine if they have had a BMD done or started on active (drug) osteoporosis therapy. If not, the fracture manager will arrange the BMD and if appropriate therapy will be started by the study physicians.

All patients will be followed for 1 year. The primary endpoints are the number of patients who get a BMD and the number who are started on active osteoporosis therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 50 or over; males or females.
  • Reside in the community or have access to bone densitometry
  • Hip fracture
  • Patient can consent or proxy consent available
  • No contraindications to bisphosphonates

Exclusion criteria

  • Patient refuses consent process
  • Already receiving active drug therapy for osteoporosis other than calcium and vitamin D
  • Dementia or delirium
  • Pathological fracture
  • Chronic corticosteroid therapy

Treatment and study plan

bone densitometry (DEXA)

Procedure

alendronate or risedronate

Drug

Primary outcomes

  1. the number of patients who get a BMD and the number who are started on active osteoporosis therapy

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research

Registry information

Official study title

Randomized Trial of Osteoporosis Intervention Strategies in Hip Fracture Patients

Important dates

Study start
2002
Study completion
2006
First posted
Aug 26, 2005
Registry last updated
Dec 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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