M34.0 M81.0
Conditions
Interventions
Group 1: Patients with systemic sclerosis > 18 years of age in outpatient or inpatient treatment who fulfill the ACR/EULAR classification criteria of 2013 and are newly starting antiresorptive therapy
Sponsors
Kerckhoff Klinik
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: > 18 years Confirmed diagnosis of SSc that meets the classification criteria Indication for osteospecific/biphosphonate therapy Bone mineral density measurement prior to the start of bisphosphonate therapy Informed written consent
Exclusion criteria
Exclusion criteria: Osteospecific therapy prior to study inclusion Contraindications for therapy with bisphosphonates Other secondary osteoporosis such as - Taking glucocorticoids > 5 mg prednisolone equivalent/day - Diabetes mellitus type I - Taking growth hormones, estrogens, aromatase inhibitors, other tumor therapy - Heart failure with a left ventricular ejection fraction < 35% - Hyperthyroidism (with the exception of hyperthyroidism factitia) - Chronic renal insufficiency from KDIGO stage G3b (GFR < 45 ml/min/1.73m²) - Hyperparathyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of antiresorptive therapy on bone mineral density of the overall cohort measured by DXA after 12 months - Subgroup analysis of the different therapeutic agents and forms of application with regard to their efficacy on bone mineral density | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapy retention rates and side effect rates in comparison of the individual preparations and application form as well as in comparison to the postmenopausal osteoporosis patient group Patient satisfaction (OPSAT-Q questionnaire) in comparison to the postmenopausal osteoporosis patient group | — |
Countries
Germany
Contacts
Public ContactNils Schulz
Kerckhoff Klinik
Outcome results
None listed