A Study of the Structural Parts of Bone in Related Diseases that Have Increased Risk of Fractures
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 13-008657
Sponsor Protocol Number: 13-008657
About this study
The purpose of this study is to examine for differences in the structural parts of bone that determine strength in individuals diagnosed with different monoclonal gammopathies (related diseases in which patients have an increased risk of fracture).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion criteria
- MGUS:
- Age 40 years or older
- Serum monoclonal protein greater than 1 g/dL, but less than or equal to 3 g/dL at the most recent clinic visit
- Bone marrow plasma cells < 10 %
- No end organ damage related to plasma cell dyscrasia including increased calcium concentration, lytic bone lesions, anemia, renal failure or a related B cell lymphoproliferative disorder.
- SMM:
- Age 40 years or older
- M-protein concentration of >3 g/dL
- > 10% plasma cells in the bone marrow
- No end organ damage (as above for MGUS)
- Newly diagnosed MM:
- Age 40 years or older
- Presence of a serum or urinary monoclonal protein
- Presence of clonal plasma cells in the bone marrow or a plasmacytoma
- Presence of end organ damage related to the plasma cell dyscrasia, such as increased calcium concentration, lytic bone lesions, anemia, or renal failure
- Have not yet started treatment for MM, such as chemotherapy or bisphosphonate treatment
- Amyloidosis:
- Age 40 years or older
- Clinically confirmed amyloidosis (blood, urine, immunostaining, and/or mass spectroscopy)
Exclusion criteria
- All groups
- > stage IV renal disease
- Treatment with any medications in the previous 12 months that can alter bone metabolism such as hormone replacement therapy, teriparatide, bisphosphonates, corticosteroids, sodium fluoride, calcitonin or antiepileptic drugs
- Females that are pregnant or breastfeeding will not be allowed to participate
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available