Clinical trial NCT04029870: Psychological Determinants of the Therapeutic Observance of Osteoporotic Patients
Official title: Psychological déterminants of the Therapeutic Observance of Osteoporotic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis, Postmenopausal
Keywords: Osteoporosis
adherence to therapy
psychological determinants
self regulation model
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 152
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will focus on a sample of 200 post-menopausal osteoporotic patients.

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.


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.

Primary outcomes:
measure: Adherence to therapy
timeFrame: Day 1
Secondary outcomes:
measure: Adherence to therapy
timeFrame: Year 1
measure: Perception of disease
timeFrame: day 1
measure: Perception of treatment
timeFrame: day 1
measure: Anxiety
timeFrame: day 1
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
state: Moselle
Study officials:
References: