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Sunday, July 4, 2010

The US FDA Approves New treatment for Osteoporosis In the form of Injectable preparation of denosumab for Postmenopausal Women

The US FDA Approves New treatment for Osteoporosis In the form of Injectable preparation of denosumab for Postmenopausal Women.
The U.S. Food and Drug Administration has announced that they have approved an injectable treatment for postmenopausal women’s who are at high risk of getting a bone fracture.

The Brand Name of this approved drug is Prolia, it is an injectable preparation containing denosumab as the active ingredient.

Information on Denosumab (Prolia):

Denosumab are nothing but the human monoclonal antibodies , these antibodies are target Receptor Activator for Nuclear Factor κ B Ligand (RANKL) it is a important factor in bone metabolism, it occurs naturally in our body and is a necessary surface-bound molecule found on osteoblasts RANKL activates osteoclasts,


Osteoclasts are the cells responsible for bone resorption. Hence overproduction of RANKL leads to number of bone degenerative diseases, like rheumatoid arthritis, osteoporosis and psoriatic arthritis.

Osteoporosis is a type of disease of bone, where in bones become fragile and patients are at high risk of getting bone fractures.

In patients where other available osteoporosis therapy does not produce desired effect or are intolerant to other available osteoporosis therapy. Prolia works to decrease the destruction of bone and helps in increasing bone mass and strength. Prolia is recommended once every six months.

Safety of use of denosumab (Prolia) was demonstrated by Amgen who has developed denosumab (Prolia 60 mg of denosumab in 1 ml of solution ) by conducting and reporting the findings of clinical trials which involved 7,808 womens, aged 60 to 90,and it was reported that about a 35% risk reduction with denosumab compared with placebo. Prolia lowered the occurrence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis.

Patients are required to be sufficiently supplemented with calcium and vitamin D.

Prolia is Contra Indicated in patients with hypocalcaemia and patients who are allergic to active or any other excipients.

The most common side effects of Prolia:

*Back pain, *Pain in the extremities, *Musculoskeletal pain, *High cholesterol levels, *. *Urinary bladder infections.

*Serious adverse reactions include hypocalcaemia (low calcium levels in the blood),

*Serious infections, including infections of the skin,

* Dermatologic reactions such as dermatitis, rashes, and eczema.

Prolia is manufactured by Amgen Manufacturing Limited, a biotechnology company and a subsidiary of Thousand Oaks, California based Amgen In.

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