Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Technische Universität Dresden297 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

297

Conditions

Myelodysplastic Syndromes

Interventions

ObservationalOTHER

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.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Universitätsklinikum Dresden

Dresden, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

Outcomes

Primary Outcomes

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.

Time frame: five years

Secondary Outcomes

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