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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00030069

Enrollment

Registered

2022-09-09

Start date

2022-07-19

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

Healthy volunteers M80 D47

Interventions

Group 1: ISM patients with osteoporosis and fractures or very low bone mineral density (BMD) < -2.5 T-score will be investigated once. 1. 1. Cytokines (TNFalpha, IL-1beta, IL-4, IL-5, IL-6, IL-8, IL1

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: indolent systemic mastocytosis

Exclusion criteria

Exclusion criteria: no bone biopsy; no bone affection

Design outcomes

Primary

Measure	Time frame
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? 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) 2. Proteomanalysis of patient serum	—

Measure

Time frame

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? 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) 2. Proteomanalysis of patient serum

—

Secondary

Measure	Time frame
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. 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.	—

Measure

Time frame

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. 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.

—

Countries

Germany

Contacts

Public ContactHeide Siggelkow

MVZ Endokrinologikum

heide.siggelkow@amedes-group.com0551-633746-0

Outcome results

None listed

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