Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Study Overview
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Brief Summary
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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).

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

Conditions
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Myelodysplastic Syndromes

Intervention / Treatment
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* Other: Observational


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1 (MDS group)<br> | Other: Observational<br>* 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.<br>|
| Group 2 (control group)<br> | Other: Observational<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, Myelodysplastic Syndromes