Clinical trial NCT02867085: Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly
Official title: A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Myelodysplastic Syndromes
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 297
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: five years
Secondary outcomes:
measure: Time-dependent molecular patterns of clonality and their association with secondary malignancies and outcome in healthy and MDS individuals
timeFrame: five years
measure: Hematological profile of MDS patients (karyotype, immunophenotype, molecular characteristics, WHO and IPSS R classification, therapy)
timeFrame: five years
measure: Sociodemographic parameters (age, sex, socioeconomic status)
timeFrame: five years
measure: Disease characteristics (onset/date of diagnosis of MDS and osteoporosis, previous treatments and diagnostic results)
timeFrame: five years
measure: Clinical osteoporotic fractures
timeFrame: five years
measure: Quality of life (QLQ C30, SF 36)
timeFrame: five years
measure: Medical care (Number of medical consultations/hospital admissions due to osteoporosis, medical professions, falls)
timeFrame: five years
measure: Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index)
timeFrame: five years
measure: Disease evolution of MDS (change of MDS subtype according to IPSS-R and WHO classification)
timeFrame: five years
measure: Disease evolution of osteoporosis (measured by number of fractures within the previous 24 months)
timeFrame: five years
measure: Overall survival
timeFrame: five years
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
Study officials:
affiliation: Universität Leipzig
name: Uwe Platzbecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Technische Universität Dresden
name: Lorenz C. Hofbauer, MD
role: PRINCIPAL_INVESTIGATOR
References: