Osteoporosis Clinical Trial
Official title:
Denosumab Versus Zoledronic Acid for Patients With Beta-Thalassemia Major-Induced Osteoporosis
This study is to compare the two medications Denosumab and Zoledronic Acid For Patients With
Beta Thalassemia Major Induced Osteoporosis. Patients with B-thalassemia major induce
osteoporosis will undergo baseline assessment of the bone densitometry by Dual-energy X-ray
absorptiometry scan as a standard of care by the radiology department, then a blood test for
bone specific Alkaline phosphatase and type-1 Carboxy Telopeptide will be measured by the
chemistry lab.
Patients with B-Thalassemia Major induced osteoporosis, who are 18 years of age or more and
willing to participate in the study will be enrolled after consenting by the primary
investigator in hematology outpatient clinic. Patients with osteoporosis will receive one of
the two medications, at the end of the year Dual-energy X-ray absorptiometry scan will be
done to compare the response of the two medications. The potential risks include the
drug-related side effects
Despite the significant improvements in the therapeutic management of beta thalassemia major
(BTM) over the past few decades, osteoporosis is still a common finding, even in optimally
treated patients. The relationships between bone mineral densities (BMD) and several clinical
characteristics or hematological markers have been described. Chronic anemia, bone marrow
expansion due to ineffective erythropoiesis, iron toxicity, calcium and zinc deficiencies,
low vitamin D levels and endocrine complications have been suggested to contribute to the
etiology of bone diseases in BTM. Nevertheless, the complex etiological mechanisms of this
heterogeneous osteopathy remain incompletely clarified. A complex mechanism controls bone
remodeling in human. This mechanism includes the receptor activator of nuclear factor kappa B
ligand (RANKL), its natural receptor (RANK) and osteoprotegerin (OPG). The RANK/RANKL pathway
is an essential to promote osteoclast formation and activation and prolongs osteoclast
survival.
OPG acts as a decoy receptor for RANKL and prevents its interaction with RANK thereby
inhibiting osteoclast formation, function, and survival. Alteration of the RANK/RANKL/OPG
system for increased osteoclastic activity and enhanced osteoblastic dysfunction is proposed
as an important mechanism in the etiology of osteoporosis in BTM. Hypogonadism, a common
finding in BTM, is associated with enhanced RANKL activity. The sex steroid hormones,
androgen, and estrogens, via their respective nuclear receptors, regulate BMD in humans and
mice. Testosterone is likely to have direct and indirect inhibitory effects on human
osteoclast formation and bone resorption. Animal model and cell culture studies suggest a
direct inhibitory effect of androgens on the OPG/RANKL cytokines system. In human
osteoblastic cells, testosterone and 5‑dihydrotestosterone mediate an androgen
receptor‑induced specific inhibition of OPG messenger ribonucleic acid (mRNA) expression.
Androgens have also been shown to block RANKL‑induced osteoclastic formation while RANKL
expression was found to be up‑regulated in osteoblastic cells from androgen
receptor‑deficient mice. The effect of oestradiol (E2) on osteoclast precursors and
osteoclasts seems to be mediated by osteoblastic cells. Inhibitory effect of E2 is associated
with the stimulated secretion of OPG by osteoblasts. Previous studies have focused on the
characteristics of thalassemic patients with osteoporosis and their response to therapy with
bisphosphonate. Because RANK‑RANKL and OPG play a significant role in bone resorption and
seem to be the principal implicated mechanism for the development of osteoporosis in BTM, we
will conduct this prospective study to evaluate the anti‑RANKL denosumab versus zoledronic
acid on TM‑induced osteoporosis.
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