pregnancy- and lactation-associated osteoporosis, methotrexate-induced osteopathy, osteoporosis in mastocytosis ORPHA:647823 Pregnancy and lactation-associated osteoporosis
Conditions
Interventions
Group 1: Patients from two DVO Osteology Centers of Excellence (Endokrinologikum Berlin and Immanuelkrankenhaus Berlin Wannsee) with one of the following rare osteological diseases: pregnancy- and lac
Sponsors
Endokrinologikum Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All adult patients in whom pregnancy-associated osteoporosis, osteoporosis in the context of mastocytosis, or methotrexate-induced osteopathy was diagnosed since the 1990s at Immanuel Hospital Wannsee or at Endokrinologikum will be included in the retrospective data analysis.
Exclusion criteria
Exclusion criteria: Exclusion criteria include an uncertain diagnosis or minor age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is to descriptively describe the cohorts of the aforementioned rare osteological diseases in Berlin, with a particular focus on identifying and descriptively describing the risk factors known for "normal" osteoporosis in these specific patient cohorts (risk factors as specified in the DVO guideline 2023). | — |
Secondary
| Measure | Time frame |
|---|---|
| Data collected include: Type of institution: Endo/IK Wannsee Patient age in years (at first manifestation and at initial diagnosis of the disease; recorded twice, as these may differ) Sex (m/f, coded as 0/1) Height in cm Weight in kg BMI calculated in kg/m² Laboratory parameters at initial diagnosis: calcium, albumin-corrected calcium, PTH, inorganic phosphate, gamma-GT, creatinine, CRP, tryptase, Beta-CrossLaps, alkaline phosphatase (AP), osteocalcin (Ostase), 25-hydroxyvitamin D Osteodensitometry: T-score lumbar spine, minimum lumbar spine T-score, total femur T-score, femoral neck T-score Fracture data: vertebral fractures (number and location, age of fractures at time of diagnosis), peripheral fractures (number and location, with particular emphasis on femoral neck and humerus; other fractures recorded separately, age of fractures at time of diagnosis) Osteoporosis medication: recorded by class (osteoanabolic vs antiresorptive; basic therapy = vitamin D and, if applicable, calcium), duration of treatment, sequential therapy Medications constituting a current or past risk factor for osteoporosis (glucocorticoids, PPIs, antiepileptics, antidepressants), duration of use, and cumulative dose Family history of parental hip fracture up to the age of 75 years Ethanol intake >50 g/day Smoking status (yes/no/pack-years) Comorbidities (rheumatoid arthritis, COPD, type 1 diabetes mellitus, type 2 diabetes mellitus, Cushing’s syndrome, hypothyroidism, hyperthyroidism, growth hormone deficiency due to pituitary insufficiency, male hypogonadism due to hormone-ablative therapy/other causes, chronic heart failure, renal insufficiency, Billroth II gastric resection or gastrectomy or bariatric surgery, monoclonal gammopathy of undetermined significance, HIV, axial spondyloarthritis, systemic lupus erythematosus, celiac disease, inflammatory bowel disease, chronic hyponatremia, falls within the past 12 months [including number], depression, neurologic | — |
Countries
Germany
Contacts
Public ContactPaula Hoff
Endokrinologikum Berlin
Outcome results
None listed