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Myelodysplastic SyndromesNCT02867085

Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

An observational study of Myelodysplastic Syndromes, run by Technische Universität Dresden at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
Observational
How many people
297 participants
Where
2 sitesGermany
Study dates
19 Jul 2017to 1 Aug 2024
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Age ≥60 years
  • With known or suspected MDS (according WHO, <20% blast count)
  • Written informed consent
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Universitätsklinikum Dresden

    Dresden, 01307

  • Universitätsklinikum Leipzig

    Leipzig, 04103

Other trials in Germany

About this study

Official title: A Prospective Longitudinal Cohort Study to Investigate 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).

Being tested
Observational
Keywords
MDS, Myelodysplastic Syndromes
Medical subject headings
Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    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.

Study groups in NCT02867085
Study groupRoleWhat they receive
Group 1 (MDS group)Not described
Receives: Other: Observational
Group 2 (control group)Not described
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: five years

Secondary outcomes (11)

  1. 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

    Measured: five years

  2. Hematological profile of MDS patients (karyotype, immunophenotype, molecular characteristics, WHO and IPSS R classification, therapy)

    Composite measures as part of a patient registry

    Measured: five years

  3. Sociodemographic parameters (age, sex, socioeconomic status)

    Composite measures as part of a patient registry

    Measured: five years

  4. Disease characteristics (onset/date of diagnosis of MDS and osteoporosis, previous treatments and diagnostic results)

    Composite measures as part of a patient registry

    Measured: five years

  5. Clinical osteoporotic fractures

    Measured: five years

  6. Quality of life (QLQ C30, SF 36)

    Composite measures as part of a patient registry

    Measured: five years

  7. Medical care (Number of medical consultations/hospital admissions due to osteoporosis, medical professions, falls)

    Composite measures as part of a patient registry

    Measured: five years

  8. Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index)

    Measured: five years

  9. Disease evolution of MDS (change of MDS subtype according to IPSS-R and WHO classification)

    Composite measures as part of a patient registry

    Measured: five years

  10. Disease evolution of osteoporosis (measured by number of fractures within the previous 24 months)

    Measured: five years

  11. Overall survival

    Duration from the day of study entry to the day of death

    Measured: five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start19 Jul 2017
  3. Primary completion1 Aug 2024
  4. Study completion1 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
297 participants (actual)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867085
Sponsor's protocol ID
BoHemE
Status last verified
Nov 2024
First submitted
27 Jul 2016
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37420006

Questions about this trial

What is this clinical trial studying?

An observational study of Myelodysplastic Syndromes, run by Technische Universität Dresden at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867085, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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