Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly

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).

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Actual): 297

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum Dresden
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The BoHemE study includes elderly patients (≥60 years) with or without MDS and age-related concomitant diseases.

The therapeutic management of patients is subject to current treatment recommendations and is determined solely by the attending physician. It is planned to include at least 356 patients (i. e. 178 per group) exhibiting the inclusion criteria.

Description

Inclusion Criteria Group 1 (MDS group):

• Age ≥60 years
• With known or suspected MDS (according WHO, <20% blast count)
• Written informed consent

Inclusion Criteria Group 2 (control group):

• Age ≥60 years
• Undergoing elective knee or hip replacement therapy
• Normal blood count (defined by Hb ♀ >12 g/dL, ♂ >13 g/dL; ANC >1.8x10^9/L; PLT >100x10^9/L)
• Written informed consent

Exclusion Criteria Group 1 (MDS group) + 2 (control group):

• History of bilateral total hip replacement prior to study
• Control group only: diagnosis of MDS or AML prior to study
• Dementia defined as MMSE score of <24
• Renal insufficiency with an eGFR <30 mL/min
• Liver cirrhosis Child-Pugh B or C
• Active infection (HIV, hepatitis B or C, tuberculosis)
• Heart insufficiency NYHA III or IV or severe cardiac valve disease
• Prior allogeneic stem cell transplantation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (MDS group)	Other: Observational; The BoHemE study does not provide any recommendations for treatment. Guidelines for osteoporosis treatment and standardized instructions for MDS patients are available, however the choice of treatment is up to the treating physician and should be reported as such.
Group 2 (control group)	Other: Observational; The BoHemE study does not provide any recommendations for treatment. Guidelines for osteoporosis treatment and standardized instructions for MDS patients are available, however the choice of treatment is up to the treating physician and should be reported as such.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Technische Universität Dresden
• Investigators: Principal Investigator: Uwe Platzbecker, MD, Universität Leipzig; Principal Investigator: Lorenz C. Hofbauer, MD, Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 1, 2024

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimated): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: MDS; Myelodysplastic Syndromes
• Additional Relevant MeSH Terms: Neoplasms; Hematologic Diseases; Precancerous Conditions; Bone Marrow Diseases; Preleukemia; Myelodysplastic Syndromes
• Other Study ID Numbers: BoHemE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No