Study Investigating the Interactions of Bone and Hematopoiesis in the Elderly

Technische Universität Dresden

Status: Completed

Conditions: Myelodysplastic Syndromes

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT02867085

BoHemE

Details and patient eligibility

About

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).

Enrollment: 297 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

297 participants in 2 patient groups

Group 1 (MDS group)

Treatment:

Other: Observational

Group 2 (control group)

Treatment:

Other: Observational