Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Completed

• Conditions: Myelodysplastic Syndromes
• Interventions: Other: Observational

• Registration Number: NCT02867085
• Lead Sponsor: Technische Universität Dresden

Brief Summary

The prospective BoHemE study is designed to evaluate the correlation between bone marrow function and skeletal health in elderly patients (\>= 60 years) with or without pre-existing myelodysplastic syndromes (MDS).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Study Start: 2017-07-19
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (control group)	Observational	-
Group 1 (MDS group)	Observational	-

Primary Outcome Measures

Name	Time	Method
T score of bone mineral density at the total hip and at lumbar spine L1-L4 in elderly patients with MDS and a control group without MDS. Osteoporosis is defined as a T score of <-2.5 at the hip and at lumbar spine L1-L4.	five years

Secondary Outcome Measures

Name	Time	Method
Quality of life (QLQ C30, SF 36)	five years	Composite measures as part of a patient registry
Clinical osteoporotic fractures	five years
Time-dependent molecular patterns of clonality and their association with secondary malignancies and outcome in healthy and MDS individuals	five years	Composite measures as part of a patient registry
Hematological profile of MDS patients (karyotype, immunophenotype, molecular characteristics, WHO and IPSS R classification, therapy)	five years	Composite measures as part of a patient registry
Sociodemographic parameters (age, sex, socioeconomic status)	five years	Composite measures as part of a patient registry
Disease characteristics (onset/date of diagnosis of MDS and osteoporosis, previous treatments and diagnostic results)	five years	Composite measures as part of a patient registry
Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index)	five years
Disease evolution of MDS (change of MDS subtype according to IPSS-R and WHO classification)	five years	Composite measures as part of a patient registry
Disease evolution of osteoporosis (measured by number of fractures within the previous 24 months)	five years
Overall survival	five years	Duration from the day of study entry to the day of death
Medical care (Number of medical consultations/hospital admissions due to osteoporosis, medical professions, falls)	five years	Composite measures as part of a patient registry

Trial Locations

Locations (2)

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Germany