Incidence of the Treatment faIlure in Osteoporosis

NCT05499403 | Completed

• 1 other identifier: TAILOR
• Study Type: observational
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Treatment Failure

Keywords

osteoporosis; treatment; fractures

Outcome Measures

Primary Outcomes (1)

• incidence of treatment failure (TF)

  incidence of TF for different type of drugs used in osteoporosis.

  60 months

Secondary Outcomes (1)

• risk factors (odds ratio)

  60 months

Eligibility Criteria

• Sex: female
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on treatment with anti-resorptives or anabolics for primary osteoporosis. We will include in the analyses all the patients evaluated in the out-patients service of our unit between 2009 and 2019 (about 5000 subjects), medical records of patients are available, medical records with missing information will be excluded. TF will be diagnosed according to the position paper of the IOF: occurrence of two fragility fractures while on treatment or one fracture plus lack of variation BMD, biochemical markers or both.

You may qualify if:

• 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

You may not qualify if:

• male gender
• glucocorticoid use (more than 3 months at any time)
• metabolic or endocrine disease with bone effect
• prolonged immobilization (patients not able to walk independently for more than 3 months at any time)
• chronic gastrointestinal disease (eg, resection or derivative surgery, inflammatory bowel disease)
• malabsorption
• multiple myeloma
• chronic obstructive pulmonary disease
• renal failure (estimated glomerular filtration rate \[GFR\]\<30 mL/min).

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Patrizia D'amelio

Lausanne, 1012, Switzerland

Location

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: August 11, 2022
• First Posted: August 12, 2022
• Study Start: May 1, 2022
• Primary Completion: December 28, 2023
• Study Completion: February 6, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

CH (1)