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Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

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ClinicalTrials.gov Identifier: NCT02867085
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

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).

Condition or disease Intervention/treatment
Myelodysplastic Syndromes Other: Observational

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 356 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 (MDS group) Other: 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.

Group 2 (control group) Other: 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.




Primary Outcome Measures :
  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 Measures :
  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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867085


Contacts
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Contact: Uwe Platzbecker, MD +49 341 197 13050 uwe.platzbecker@medizin.uni-leipzig.de
Contact: Anna Mies, PhD +49 351 458 5942 anna.mies@ukdd.de

Locations
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Germany
Universitätsklinikum Dresden Recruiting
Dresden, Germany, 01307
Contact: Lorenz C. Hofbauer, MD         
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Uwe Platzbecker, MD         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
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Principal Investigator: Uwe Platzbecker, MD Universität Leipzig
Principal Investigator: Lorenz C. Hofbauer, MD Technische Universität Dresden

Additional Information:

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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02867085     History of Changes
Other Study ID Numbers: BoHemE
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Keywords provided by Technische Universität Dresden:
MDS
Myelodysplastic Syndromes
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms