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Bone Safety
Bone Structure
A.Align to biomechanical loading

Anatomical structure of bones depends mainly on the genetic and biomechanical influences to their length, width, shape and contour, and strength. In general, mechanical rules, structure alignment streams along the loading axis.

B.Cortex and trabecular

Bone has a cortical shell as the predominant weight bearing component and trabeculae as the sponge cushion within the marrow.

C.Blood Supply

Bone marrow is the source for hematopoiesis, therefore has distinct blood supply networks.

Bone Resorption vs Bone Formation

Maintenance of bone integrity is crucial to hematopoiesis, locomotion, and muscle/tendon insertion; and is pivotal to calcium homeostasis, hormonal metabolism and weight bearing activities. Bone mass is gained through remodeling, where bone formation is greater than that of bone resorption. Bone loss occurring during aging is due to greater bone resorption than bone formation.

Drug Effects

Maintenance of bone mass occurs when the cumulative sum of bone resorption and formation by the basic multicellular units (BMUs) is in balance. Drugs that are distributed through blood flow can easily affect the balance of bone resorption and formation. Numerous known chemicals, such as fluoride, aluminum, lead, etc. as well asinflammation/immune modulators, such as cyclosporine, steroids, conjugated antibodies, etc. can have detrimental effects on bone physiology and lead to bone pathology with increased risk of fracture as the end result. It is therefore prudent to examine the influence of medicinal products, whether small molecules or protein-based agents, on bone for safety purposes.

Bone Safety Studies
Bone Safety Studies should be performed for:

·     Compounds that are known to modify the bone remodeling process

·     Compounds that may have an effect on calcium homeostasis, PTH/CT/1,25VitD axis

·     Compounds that alters the differentiation of marrow cells

·     Compounds that is composed of heavy metals Compound that may affect gonadal hormones

·     Compounds that will be given to pediatric patients or patients with renal disorders

·     Compounds that may have an effect at the pituitary/hypothalamus axis

Tools Used by the Bone Biologist

·     Bone markers (Turnover, Formation and Resorption Markers)

·     Bone Mass/ Mineral Density Determinations (X-ray, DXA, pQCT, CT scan  and Micro-CT) Bone Strength Determinations (Biomechanical Testing)

·     Bone Histomorphometry

·     Histopathology


Histomorphometry Parameters

Static parameters:

bone area/perimeter and

Dynamic parameters:

bone formation rate

Cellular parameters:

osteoblasts, osteoclasts,

Unusual tissues:

fibrosis, woven bone, excessive osteoid, diffused bone formation, defect and repair area, implant/bone surface

Exotic parameters:

wall width, activation frequency, mineralization lag time

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