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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033393

Enrollment

Registered

2024-01-15

Start date

2024-02-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M80.8 M81.8 M34

Interventions

Group 1: Retrospective evaluation of patients with systemic sclerosis and bone density reduction with indication and implementation of antiresorptive therapy as well as additional bone density measure

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in bone density measured by DXA at the start of therapy and after 2 years of antiresorptive therapy	—

Secondary

Measure	Time frame
Superiority of individual drugs in terms of bone density increase/loss measured by DXA over 2 years 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 Dependence of treatment effectiveness measured in bone density gain/loss by DXA on gender, age and duration of disease Dependence of treatment effectiveness measured in bone density gain/loss by DXA on vitamin D status Differences in the treatment retention rates of individual drugs Number and type of side effects reported Number and type of fractures under treatment	—

Measure

Time frame

Superiority of individual drugs in terms of bone density increase/loss measured by DXA over 2 years 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 Dependence of treatment effectiveness measured in bone density gain/loss by DXA on gender, age and duration of disease Dependence of treatment effectiveness measured in bone density gain/loss by DXA on vitamin D status Differences in the treatment retention rates of individual drugs Number and type of side effects reported Number and type of fractures under treatment

—

Countries

Germany

Contacts

Public ContactNils Schulz

Justus-Liebig-Universität, Campus Kerckhoff

n.schulz@kerckhoff-klinik.de06032/996-6064

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026