JOURNAL ONKOLOGIE – STUDIE

Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT02867085

Studienbeginn:
Juli 2017

Letztes Update:
11.08.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Preleukemia, Myelodysplastic Syndromes

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Technische Universität Dresden

Collaborator:
-

Studienleiter

Uwe Platzbecker, MD
Principal Investigator
Universität Leipzig

Lorenz C. Hofbauer, MD
Principal Investigator
Technische Universität Dresden

Kontakt

Uwe Platzbecker, MD
Kontakt:
Phone: +49 341 197 13050
E-Mail: uwe.platzbecker@medizin.uni-leipzig.de» Kontaktdaten anzeigen

Anna Mies, PhD
Kontakt:
Phone: +49 351 458 5942
E-Mail: anna.mies@ukdd.de» Kontaktdaten anzeigen

Studienlocations
(2 von 2)

Universitätsklinikum Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Lorenz C. Hofbauer, MD» Ansprechpartner anzeigen

Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Uwe Platzbecker, MD» Ansprechpartner anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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. (Time Frame - five years)

Secondary outcome:

1. Time-dependent molecular patterns of clonality and their association with secondary malignancies and outcome in healthy and MDS individuals (Time Frame - five years):
Composite measures as part of a patient registry

2. Hematological profile of MDS patients (karyotype, immunophenotype, molecular characteristics, WHO and IPSS R classification, therapy) (Time Frame - five years):
Composite measures as part of a patient registry

3. Sociodemographic parameters (age, sex, socioeconomic status) (Time Frame - five years):
Composite measures as part of a patient registry

4. Disease characteristics (onset/date of diagnosis of MDS and osteoporosis, previous treatments and diagnostic results) (Time Frame - five years):
Composite measures as part of a patient registry

5. Clinical osteoporotic fractures (Time Frame - five years)

6. Quality of life (QLQ C30, SF 36) (Time Frame - five years):
Composite measures as part of a patient registry

7. Medical care (Number of medical consultations/hospital admissions due to osteoporosis, medical professions, falls) (Time Frame - five years):
Composite measures as part of a patient registry

8. Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index) (Time Frame - five years)

9. Disease evolution of MDS (change of MDS subtype according to IPSS-R and WHO classification) (Time Frame - five years):
Composite measures as part of a patient registry

10. Disease evolution of osteoporosis (measured by number of fractures within the previous 24 months) (Time Frame - five years)

11. Overall survival (Time Frame - five years):
Duration from the day of study entry to the day of death

Studien-Arme

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

Geprüfte Regime

Observational:
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.

Quelle: ClinicalTrials.gov

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