Myelodysplastic Syndromes
Conditions
Keywords
MDS, Myelodysplastic Syndromes
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).
Interventions
OTHERObservational
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.
Sponsors
Technische Universität Dresden
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Clinical osteoporotic fractures | five years | — |
| Quality of life (QLQ C30, SF 36) | five years | Composite measures as part of a patient registry |
| 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 |
| 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 |
Countries
Germany
Outcome results
None listed