Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

297 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-19

Study Completion Date

2024-08-01

Brief Summary

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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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Detailed Description

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Conditions

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Myelodysplastic Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1 (MDS group)

Observational

Intervention Type 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.

Group 2 (control group)

Observational

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No