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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

Tracking Information
First Submitted Date July 27, 2016
First Posted Date August 15, 2016
Last Update Posted Date August 26, 2019
Actual Study Start Date July 19, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 10, 2016)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 10, 2016)
  • 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
  • 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
  • Sociodemographic parameters (age, sex, socioeconomic status) [ Time Frame: five years ]
    Composite measures as part of a patient registry
  • 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
  • Clinical osteoporotic fractures [ Time Frame: five years ]
  • Quality of life (QLQ C30, SF 36) [ Time Frame: five years ]
    Composite measures as part of a patient registry
  • 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
  • Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index) [ Time Frame: five years ]
  • 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
  • Disease evolution of osteoporosis (measured by number of fractures within the previous 24 months) [ Time Frame: five years ]
  • Overall survival [ Time Frame: five years ]
    Duration from the day of study entry to the day of death
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly
Official Title A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly
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).
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
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.

Condition Myelodysplastic Syndromes
Intervention 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.
Study Groups/Cohorts
  • Group 1 (MDS group)
    Intervention: Other: Observational
  • Group 2 (control group)
    Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 10, 2016)
356
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02867085
Other Study ID Numbers BoHemE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Technische Universität Dresden
Study Sponsor Technische Universität Dresden
Collaborators Not Provided
Investigators
Principal Investigator: Uwe Platzbecker, MD Universität Leipzig
Principal Investigator: Lorenz C. Hofbauer, MD Technische Universität Dresden
PRS Account Technische Universität Dresden
Verification Date August 2019