NCT05499403Completed
Incidence of the Treatment faIlure in Osteoporosis
Treatment fAIlure in Osteoporosis: Who Will Experience a New fRacture? The TAILOR Study
Source: ClinicalTrials.gov · Last updated 12 Mar 2024
Brief summary (registry, in English)
Osteoporotic fractures are associated with significant morbidity, increased mortality and reduction in the quality of life, available treatments reduces the fracture risk between 30 and 70%, however some patients experience a new fracture and/or continue to loose bone during treatment; this has been defined as treatment failure (TF). The epidemiology and biological bases of TF are currently under-investigated, thus it is impossible for the physician to forecast patients' answer to treatment. The aims of TAILOR study are to collect sounded epidemiological data on TF in a real life setting. To this extent, the investigators will retrospectively a large cohort of 5000 patients with at least 60 months of anti-osteoporotic treatment followed in our center for the diagnosis and care of bone metabolic diseases, and compare TF patients to adequate responders (ARs) for clinical characteristic and biological parameters. The results will be a "signature" to identify those patients who will experience TF.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 415 (actual)
- First submitted
- 11 Aug 2022
- Start date
- 1 May 2022
- Primary completion date
- 28 Dec 2023
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Diseases
- Osteoporosis
- NCT number
- NCT05499403
What you commit to
- Study type: Observational
- Participants enrolled: 415
- From 1 May 2022 to the primary completion date, 28 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- metabolic or endocrine disease with bone effect
- chronic gastrointestinal disease (eg, resection or derivative surgery, inflammatory bowel disease)
- chronic obstructive pulmonary disease
Lab values
- renal failure (estimated glomerular filtration rate \[GFR\]\<30 mL/min).
Other
- male gender
- glucocorticoid use (more than 3 months at any time)
- prolonged immobilization (patients not able to walk independently for more than 3 months at any time)
- malabsorption
- multiple myeloma
Who the study is looking for
- patients affected by post-menopausal osteoporosis
- patients treated for at least 12 months and up to 10 years with drugs active on bone turnover
- patients with at least one follow-up visit in the period considered by the study
Sex: Female
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Patrizia D'amelio Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.