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NCT Number: NCT02867085

Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

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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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Dresden, Dresden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2016
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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