Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Myelodysplastic Syndromes Clinical Trial

Official title:

A Prospective Longitudinal Cohort Study to Investigate the Interactions of Bone and Hematopoiesis in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02867085
• Other study ID #: BoHemE
• Status: Recruiting
• Start date: July 19, 2017
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Technische Universität Dresden
• Contact: Uwe Platzbecker, MD
• Phone: +49 341 197 13050
• Email: uwe.platzbecker[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 356
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

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.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Dresden	Dresden
Germany	Universitätsklinikum Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	five years
Secondary	Hematological profile of MDS patients (karyotype, immunophenotype, molecular characteristics, WHO and IPSS R classification, therapy)	Composite measures as part of a patient registry	five years
Secondary	Sociodemographic parameters (age, sex, socioeconomic status)	Composite measures as part of a patient registry	five years
Secondary	Disease characteristics (onset/date of diagnosis of MDS and osteoporosis, previous treatments and diagnostic results)	Composite measures as part of a patient registry	five years
Secondary	Clinical osteoporotic fractures		five years
Secondary	Quality of life (QLQ C30, SF 36)	Composite measures as part of a patient registry	five years
Secondary	Medical care (Number of medical consultations/hospital admissions due to osteoporosis, medical professions, falls)	Composite measures as part of a patient registry	five years
Secondary	Comorbidities (Hematopoietic Cell Transplantation-specific Comorbidity Index)		five years
Secondary	Disease evolution of MDS (change of MDS subtype according to IPSS-R and WHO classification)	Composite measures as part of a patient registry	five years
Secondary	Disease evolution of osteoporosis (measured by number of fractures within the previous 24 months)		five years
Secondary	Overall survival	Duration from the day of study entry to the day of death	five years