NCT03994094

Brief Summary

A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis. The effectiveness specialized osteoporosis clinics is the subject of numerous publications. It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 12, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 21, 2019

Status Verified

June 1, 2019

Enrollment Period

1 month

First QC Date

June 20, 2019

Last Update Submit

August 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of fractures since the enrollment in the clinic

    Number of incident fractures suffered by the patient since their enrollment in the osteoporosis clinic.

    From the enrollment of patients between january 2012 and december 2015 to the interview date

Secondary Outcomes (2)

  • Evolution of bone mineral density since the enrollment in the clinic

    From the enrollment of patients between january 2012 and december 2015 to the interview date

  • Satisfaction with the osteoporosis clinic

    From the enrollment of patients between january 2012 and december 2015 to the interview date

Interventions

Structured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who were enrolled in the cohort of the osteoporosis clinic of our hospital between january 2012 and December 2015 following an osteoporotic fracture.

You may qualify if:

  • Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015
  • Acceptation of the telephone interview

You may not qualify if:

  • Age \< 18 years
  • No social security coverage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, France

Location

MeSH Terms

Conditions

OsteoporosisOsteoporotic Fractures

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Bénédicte Haettich, MD

    Centre Hospitalier du Mans, Rheumatology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 21, 2019

Study Start

June 12, 2019

Primary Completion

July 20, 2019

Study Completion

September 1, 2019

Last Updated

August 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations