Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

NCT02867085 | Completed

• 1 other identifier: BoHemE
• Study Type: observational
• Target: 297
• Locations: 1 country
• Sites: 2

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).

Conditions

Myelodysplastic Syndromes

Keywords

MDS; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Time-dependent molecular patterns of clonality and their association with secondary malignancies and outcome in healthy and MDS individuals

  five years

• Hematological profile of MDS patients (karyotype, immunophenotype, molecular characteristics, WHO and IPSS R classification, therapy)

  five years

• Sociodemographic parameters (age, sex, socioeconomic status)

  five years

• Disease characteristics (onset/date of diagnosis of MDS and osteoporosis, previous treatments and diagnostic results)

  five years

• Clinical osteoporotic fractures

  five years

Study Arms (2)

Group 1 (MDS group)

Other: Observational

Group 2 (control group)

Other: Observational

Interventions

Observational OTHER

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 1 (MDS group); Group 2 (control group)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (2)

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Related Publications (1)

• Schneider M, Rolfs C, Trumpp M, Winter S, Fischer L, Richter M, Menger V, Nenoff K, Grieb N, Metzeler KH, Kubasch AS, Sockel K, Thiede C, Wu J, Woo J, Bruderle A, Hofbauer LC, Lutzner J, Roth A, Cross M, Platzbecker U. Activation of distinct inflammatory pathways in subgroups of LR-MDS. Leukemia. 2023 Aug;37(8):1709-1718. doi: 10.1038/s41375-023-01949-2. Epub 2023 Jul 7.

  PMID: 37420006 DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Uwe Platzbecker, MD

  Universität Leipzig

  PRINCIPAL INVESTIGATOR

• Lorenz C. Hofbauer, MD

  Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: August 15, 2016
• Study Start: July 19, 2017
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)