Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Sponsor
Technische Universität Dresden (Other)
Overall Status
Recruiting
CT.gov ID
NCT02867085
Collaborator
(none)
356
2
76.4
178
2.3

Study Details

Study Description

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 Phase
  • Other: Observational

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
356 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly
Actual Study Start Date :
Jul 19, 2017
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

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. [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 [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) [five years]

    Composite measures as part of a patient registry

  3. Sociodemographic parameters (age, sex, socioeconomic status) [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) [five years]

    Composite measures as part of a patient registry

  5. Clinical osteoporotic fractures [five years]

  6. Quality of life (QLQ C30, SF 36) [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) [five years]

    Composite measures as part of a patient registry

  8. Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index) [five years]

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

  11. Overall survival [five years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsklinikum Dresden Dresden Germany 01307
2 Universitätsklinikum Leipzig Leipzig Germany 04103

Sponsors and Collaborators

  • Technische Universität Dresden

Investigators

  • Principal Investigator: Uwe Platzbecker, MD, Universität Leipzig
  • Principal Investigator: Lorenz C. Hofbauer, MD, Technische Universität Dresden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT02867085
Other Study ID Numbers:
  • BoHemE
First Posted:
Aug 15, 2016
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Keywords provided by Technische Universität Dresden
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2021