Osteopenia and osteoporosis
Conditions
Interventions
Group 1: PFC (Post Fracture Care)
High-risk patients (men =50 years, postmenopausal women) with manifest osteoporosis, identified during inpatient treatment of an acute fragility fracture at the Depar
data collection (clinical characteristics, osteological diagnostics, pharmacological therapy, adherence, fracture risk, mobility, quality of life) accompanies the post-inpatient care transition and fo
clinical characteristics, osteological diagnostics, pharmacological therapy, adherence, fracture risk, and patient-relevant parameters (mobility, quality of life) are recorded as part of routine clini
Sponsors
Institut für Muskuloskelettale Medizin (IMM), LMu Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age =18 years Capacity to consent
Exclusion criteria
Exclusion criteria: Minors and lack of capacity to consent Dementia Legal guardianship Severe comorbidities that make participation impossible (e.g., hospitalisation, nursing home residency, bedriddenness). These patients are considered separately within the scope of an already approved study (Project No.: 25-0120, Dr. Vera Smolka). Substance abuse Rare skeletal disorders (Note: Only patients with a previously confirmed monogenic disease are excluded. Patients in whom no genetic disease was initially known but who are diagnosed with one during the course of the study are included in the OSTEO-REAL study and separately documented.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In all four care arms (PFC, U-OPC, DMP, P-OPC), the individual fracture risk according to the current national osteoporosis guideline (DVO guideline), guideline-conformity of the initiated pharmacological therapy, and fall risk (including fall history, Timed Up & Go test, Chair-Rising test, and grip strength measurement) are assessed. At study enrolment, a retrospective assessment of the patient's prior medical history is performed. Subsequently, these parameters are documented prospectively and continuously at each clinically indicated routine visit (outpatient consultation at the LMU University Hospital or at the cooperating practice) until withdrawal of consent, death, dropout, or end of study. Data are collected using standardized questionnaires that are integrated into routine clinical care (paper-based or digital via the REDCap Mobile App), supplemented by diagnostic results entered by the study team from the medical record (e.g., bone density measurement, osteological laboratory parameters). Data are uniformly entered into the REDCap data management system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-relevant parameters such as quality of life (EQ-5D-5L), pain (VAS), mobility, independence, and sarcopenia risk (SARC-F) are assessed, along with treatment adherence. In addition, the processes and interfaces between inpatient and outpatient as well as intersectoral care (between the university outpatient clinic and the cooperating practice) are analysed to identify potential for optimisation, as well as approaches for individualised preventive medicine concepts. Data are collected analogously to the primary outcome, retrospectively at enrolment and prospectively at each subsequent clinically indicated visit over the five-year study period. Data are collected using standardized questionnaires (EQ-5D-5L, SARC-F, VAS, and a self-assessment questionnaire on health status) in paper-based or digital form via the REDCap Mobile App, supplemented by clinical data from the medical record; documentation is uniformly recorded in REDCap. | — |
Countries
Germany
Contacts
Public ContactEric Hesse
Institut für Muskuloskelettale Medizin (IMM), LMU Klinikum
Outcome results
None listed