NCT01627483

Brief Summary

The aim of this study is to investigate if prescribing of fall-risk increasing and fracture-preventing drugs can be improved in older hip fracture patients by assessments of risks of falls and fractures and medication reviews performed by a physician and forwarded to prescribing physicians.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 21, 2012

Last Update Submit

June 21, 2012

Conditions

Keywords

elderlyhip fractureosteoporosisfall riskmedication review

Outcome Measures

Primary Outcomes (2)

  • Treatment with fall-risk-increasing drugs

    Drug treatment is estimated from the Swedish Register of Dispensed Drugs

    One year

  • Treatment with fracture-preventing drugs

    Drug treatment is estimated from the Swedish Register of Dispensed Drugs

    One year

Secondary Outcomes (3)

  • Attitudes towards the intervention among physicians

    Ten months

  • Fall-related injuries in need of medical care

    One year

  • Death

    One year

Study Arms (2)

Medication review

EXPERIMENTAL

Assessment of risks of falls and fractures, medication review

Other: Medication review

Controll

NO INTERVENTION
Other: Medication review

Interventions

Assessment of risks of falls and fractures; medication review concerning fall-risk-increasing and fracture-preventing drugs; oral and written feed back of the results of the assessments and medication reviews to the hospital physician during the hospital stay and to the general practitioner 3 and 6 months after the hip fracture surgery.

ControllMedication review

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • hip fracture surgery at Sahlgrenska University Hospital/Mölndal
  • aged 65 years and over
  • residing in the Gothenburg area

You may not qualify if:

  • own opposition to participation
  • if not able to give informed consent, opposition to participation by next of kin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital/Mölndal

Mölndal, Region Västra Götaland, 431 80, Sweden

Location

Related Publications (1)

  • Sjoberg C, Bladh L, Klintberg L, Mellstrom D, Ohlsson C, Wallerstedt SM. Treatment with fall-risk-increasing and fracture-preventing drugs before and after a hip fracture: an observational study. Drugs Aging. 2010 Aug 1;27(8):653-61. doi: 10.2165/11538200-000000000-00000.

    PMID: 20658793BACKGROUND

MeSH Terms

Conditions

Hip FracturesOsteoporosis

Interventions

Medication Review

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Medication SystemsOrganization and AdministrationHealth Services AdministrationPatient Care Management

Study Officials

  • Susanna M Wallerstedt, Assprofessor

    Department of Clinical Pharmacology, Sahlgrenska University Hospital, Bruna stråket 21, S-413 45 Gothenburg, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

September 1, 2010

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations