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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (MDS group) |
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| Group 2 (control group) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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Inclusion Criteria Group 1 (MDS group):
Inclusion Criteria Group 2 (control group):
Exclusion Criteria Group 1 (MDS group) + 2 (control group):
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Uwe Platzbecker, MD | Universität Leipzig | Principal Investigator |
| Lorenz C. Hofbauer, MD | Technische Universität Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Dresden | Dresden | 01307 | Germany | |||
| Universitätsklinikum Leipzig |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37420006 | Derived | 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. |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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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 |
| Leipzig |
| 04103 |
| Germany |