Prospective study to the pathogenesis of osteoporosis in patients with indolent systemic mastocytosis

Recruiting

• Conditions: Healthy volunteers; M80; D47; Osteoporosis with pathological fracture; Other neoplasms of uncertain or unknown behaviour of lymphoid, haematopoietic and related tissue

• Registration Number: DRKS00030069
• Lead Sponsor: MVZ-Endokrinologikum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

indolent systemic mastocytosis

Exclusion Criteria

no bone biopsy; no bone affection

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison between patients with Mastocytosis with and without osteoporosis and controls Are there differences between cytokines and proteom analysis in serum? Does the number of circulating osteoprogenitor cells from EDTA blood differ between the groups? <br>Blood from patients will be analyzed and compared what concerns mast cell mediators. Serum from patients with osteoporosis (T-score =-2,5 > 50 Jahre, Z-Score = -2,5 = 50 years of age)/or fractures will be compared with patients without fractures and normal bone mineral density (= -1,50 T-score; = -1,5 Z-score (in patients < 50 years) The following parameters will be investigated: 1. 1. Cytokines (TNFalpha, IL-1beta, IL-4, IL-5, IL-6, IL-8, IL13, IL-17, FGF und TGF-beta) <br><br>2. Proteomanalysis of patient serum

Secondary Outcome Measures

Name	Time	Method
To be able to investigate bone parameters in the peripheral blood circulating osteoblast progenitor cells (COP) will be analyzed and sorted für DNA and RNA analysis. COP cells are bone cells from the bone marrow and move to areas where needed like fractures. If a sufficient number can be isolated cells will be analyzed by DNA and RNA methods. In addition DNA from peripheral blood will be generated for analysis of genes relevant for bone metabolism. <br>In addition questionnaires are used to investigate Quality of life and pain to evaluate for differences between those with and without osteoporosis and controls. the following questionnaires will be used SF-36, MC-QoL und Mastocytosis activity score (MAS) and the German pain questionnaire.