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PAmidronate for Pain in Sternocostoclavicular hyperostosis: the PAPS-study, a double-blind randomized placebo-controlled trial

Phase 1
Recruiting
Conditions
Inflammation of sternal region, Sternocostoclavicular hyperostosis
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Registration Number
CTIS2023-510309-16-00
Lead Sponsor
Academisch Ziekenhuis Leiden
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
70
Inclusion Criteria

NRS score for maximal pain of = 6/10 at lesion sites, Signs of disease activity on imaging at lesion sites, No treatment with bisphosphonates for the previous 6 months

Exclusion Criteria

Age below 18 years of age, Mental disability, Active pregnancy wish, pregnancy or nursing, Generalized pain without CNO related pain, Bisphosphonate allergy, Estimated glomerular filtration rate < 30 ml/min, Uncontrolled endocrine abnormalities, Active cancer treatment, Language barrier, Severe co-morbidity, including poor mobility and other causes preventing attendance for control visits

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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