Effectiveness of antiresorptive drugs in patients with systemic sclerosis and osteoporosis - a retrospective monocentric study

Recruiting

Conditions: M80.8
M81.8
M34
Other osteoporosis with pathological fracture
Other osteoporosis
Systemic sclerosis

Registration Number: DRKS00033393

Lead Sponsor: Justus-Liebig-Universität, Campus Kerckhoff

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

Positive classification of the ACR/EULAR classification criteria for systemic sclerosis from 2013

Bone density reduction (osteoporosis/osteopenia) with indication for osteospecific therapy according to DVO guideline 2017

Treatment with bisphosphonates, raloxifene or denosumab

Presence of at least 2 bone density measurements (DXA) (before and during or after osteospecific therapy; interval of 2 years between measurements)

Exclusion Criteria

Interrupted therapy with antiresorptive drugs

Undergoing osteoanabolic therapy

Other secondary forms of osteoporosis, in particular:
- Intake of > 5 mg prednisolone equivalent/day
- Diabetes mellitus type I
- Intake of growth hormones, estrogens, aromatase inhibitors, other tumor therapies
- Heart failure with an EF < 35 %
- Hyperthyroidism (with the exception of hyperthyroidism factitia)
- Chronic renal insufficiency KDIGO stage 3b or higher
- Hyperparathyroidism

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in bone density measured by DXA at the start of therapy and after 2 years of antiresorptive therapy

Secondary Outcome Measures

Name	Time	Method
Superiority of individual drugs in terms of bone density increase/loss measured by DXA over 2 years<br><br>Correlation between the effectiveness of osteospecific therapy measured in bone density gain/loss by DXA and esophageal atony (detected by CT) or the degree of skin fibrosis measured by mRSS<br><br>Dependence of treatment effectiveness measured in bone density gain/loss by DXA on gender, age and duration of disease<br><br>Dependence of treatment effectiveness measured in bone density gain/loss by DXA on vitamin D status<br><br>Differences in the treatment retention rates of individual drugs<br><br>Number and type of side effects reported<br><br>Number and type of fractures under treatment