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Clinical Trials/NCT04029870
NCT04029870
Completed
Not Applicable

Psychological déterminants of the Therapeutic Observance of Osteoporotic Patients

Centre Hospitalier Régional Metz-Thionville1 site in 1 country152 target enrollmentJune 17, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoporosis, Postmenopausal
Sponsor
Centre Hospitalier Régional Metz-Thionville
Enrollment
152
Locations
1
Primary Endpoint
Adherence to therapy
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures.

On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy.

The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.

Registry
clinicaltrials.gov
Start Date
June 17, 2019
End Date
January 31, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Centre Hospitalier Régional Metz-Thionville
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be treated with an anti-osteoporotic drug for at least three months
  • Mastering the French language orally and in writing
  • Have obtained the patient's oral agreement to participate in the research
  • Present post-menopausal osteoporosis
  • Present a densitometric osteoporosis with a T-score (-2.5) treated medically per OS (example: biphosphonates) or by subcutaneous injection (example: prolia)
  • Present a history of severe osteoporotic fractures after falls of its height.

Exclusion Criteria

  • Present a psychiatric history
  • Present an intellectual disability
  • Present major cognitive disorders related to neurodegenerative disease or other nervous system disorders.

Outcomes

Primary Outcomes

Adherence to therapy

Time Frame: Day 1

The influence of psychological emission on the therapeutic adherence is measured with an adherence scale (EGOMAC) which includes 3 items: drugs observance, hygiene compliance and dietary restrictions. The item are scored on a 4-point scale with 1-strongly disagree; 2-disagree, 3-agree and 4-fully agree.

Secondary Outcomes

  • Anxiety(day 1)
  • Perception of disease(day 1)
  • Adherence to therapy(Year 1)
  • Perception of treatment(day 1)

Study Sites (1)

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