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Boniva Review Article

 

Fig1. Growing old is a part of life
B0NIVA AND OSTEOPOROSIS
Boniva (Generic Name: Ibandronic Acid or Ibandronate Sodium) is a drug that is used for preventing and treating oseteoporosis, an illness that weakens the bones and makes it fragile, in post-menopausal women who have high risks of having bone fractures. It is a potent biphosphonate which may also be used for the treatment of hypercalcemia, a condition wherein levels of calcium in the blood is elevated. Biphosphonate inhibits the action of osteoclasts which are cells in the body that break down bone tissue. This results in less bone loss. Studies show that this drug can significantly reduce the risk for developing spine fractures. However, its efficacy in decreasing the risk for developing neck and femur fractures has not yet been established. Aging is part of the cycle of life. Each and every one of us will one day have to grow old. There are several changes that come with aging, like physical weakening, decreased memory and mental cognition, and increased susceptibility to diseases. The elderly population is a group that has many medical concerns, one of which is osteoporosis. Continue reading...

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Osteoporosis is defined as a progressive bone disease that decreases bone mass, causing serious deterioration of the bone structure (Merck Manual). This continuous process of bone loss increases the risk of an individual for bone fracture (like hip fracture, wrist fracture, rib fracture, and others). Osteoporosis is considered to be a serious public health concern (National Osteoporosis Foundation), affecting about 44 million women and 50 million men in the United States.

There is no specific sign or symptom in osteoporosis. The most common sign among patients perhaps is the chronic pain felt from a bone fracture. Fractures are only a consequence of bone fragility brought about by osteoporosis. These occur only after the disease has progressed long enough. Thus, most people do not know they have the disease until the first fracture develops.

Though a strong impact or injury is necessary to cause a fracture on the bone, osteoporotic fractures are different. Osteoporosis causes the bone to become significantly weak and porous, that minor trauma (or sometimes no trauma at all) can cause fractures. Bone fractures are often the cause short and long term morbidities, as well as mortalities associated with osteoporosis. In a recent report by the WHO, there is an approximately 1.66 million hip fractures all over the world. This number is estimated to increase three times by 2050 (WHO). Hip fracture can often result to premature death – the reason why this disease is considered to be “an impending epidemic”, due to the serious morbidities and projected increase in cases.

To make an accurate diagnosis of osteoporosis, it is necessary to determine the bone mineral density (BMD) of a patient. A dual-emmision x-ray absorptiometry or DXA is used for this purpose. According to the World Health Organization, low bone mass is defined as having bone mineral density of 2.5 or more standard deviations below from the mean peak bone mass, as measured by DXA. Aside from BMD, other indicative factors include bone fracture xray, family history and heightloss due to vertebral fracture.

Normally, the bone is under homeostatic balance of continuous resorption by osteoclasts, and formation by osteoblasts. These cells are regulated by several hormones - parathyroid hormone (PTH) promotes resoption while calcitonin and estrogen promote bone formation. In osteoporosis, there is excessive bone loss, which is usually caused by excessive bone resorption activity by osteoclasts. Thus, drugs that are effective for halting osteoclast activity are a good method of treating osteoporosis. Boniva, or Ibandronate Sodium is one such drug.

Boniva

Boniva, or Ibandronate sodium, is a potent bone resorption inhibitor belonging to the Nitrogen containing bisphosphonate drug class. Its molecular formula is C9H22NNaO7 and its structural formula is:
Fig 2. Boniva (Ibandronate Sodium)
Boniva is a prescription drug approved by the US Food and Drug Administration (FDA) for the treatment and prevention of postmenopausal osteoporosis.

As stated above, Boniva inhibits osteoclast activity. Boniva, like all other bisphosphonates, are structurally similar to pyrophosphate, which is an integral part of hydroxyapatite – a part of the mineral matrix of the bones. Bisphosphonates bind to calcium in the bones. When osteoclasts starts bone resorption, they “ingest” bisphosphonates in which these cell breaks down. The resulting metabolism of bisphosphonates leads to farnesyl diphosphate synthase (FPPS) inhibition, which is important in the mevalonic acid pathway (van Beek, Cohen, Leroy, et al., 2003). This pathway is the main p method of energy production in osteoclasts; inhibition of which ultimately leads to the inhibition of the bone resorption activity (Akesson, 2003).

Boniva’s Effectiveness

Several studies have proven that Boniva is effective for the treatment and prevention of osteoporosis. Among the different oral bisphosphonates available in the market, Boniva has been found to be the most potent (Ravn et al., 1996). The group found an overall increase in bone mass in all skeletal regions. Boniva is currently prescribed (and found effective) as once daily, once weekly and even once monthly treatment.

However the FDA states that the safety of the drug is approved only for three years; no study as of yet has shown effectiveness or safety after three years of use.

Hypercalcemia in Malignancy

Another disease in which there is excessive bone resorption is bone malignancy. This type of cancer often leads to hypercalcemia, though this develops after a significant time where the tumor has reached an advanced stage. This cancer is initiated by circulating tumours settling in the bones, wherein they stimulate osteoclast activity (Mundy, 1989).

Due to the involvement of osteoclasts, bisphophonates have been used for the treatment and reversal of hypercalcemia in bone malignancy. Wustler et al. (1993) found that 2mg I.V. doses were effective. In another study by Ralston et al. (1997), they found that 4 and 6 mg doses were more effective.

Dosage Forms

It was found that bisphosphonates has a very low therapeutic adherence. This may be due to geriatric patients’ attitude or behaviour regarding drug use. This affects the overall effectiveness of the drug - intermittent treatment hinders complete control of bone deterioration with osteoporosis. However, there is one drug that has been confirmed to be effective despite less frequent dosing. Boniva is the first once monthly oral biphosphonate approved for use (Bauss & Schimmer, 2006).

Boniva has high antiresorptive potency – which means that the drug requires lower doses to achieve the same effectiveness. The half life of the drug is estimated to be about ten years in the bone. Aside from that, the drug has an excellent safety profile. These reasons make the Boniva a perfect candidate for extending the dosing intervals.

Preclinical studies made by Smith et al. (2003) and Muller et al. (2004) in monkeys, Lalla et al. (1998) in rats, and Monier-Faugere et al. (1993) in dogs have all shown that a 30 day interval of doses was effective in suppressing induced bone deterioration. Later on, clinical trials made by Ravn et al. (1996), and Schimmer and Bauss (2003) have proven that a once monthly dose is effective; in fact, this dose regime was found to be at par or even superior than the daily dose Boniva regimen. A more recent study by Chestnut III and colleagues (2004) support these findings as well.

Cancer of the Esophagus

Last July 2011, the FDA has issued a warning to all health care professionals and patients who are using Boniva. The warning was about the suspected risk of developing cancer of the esophagus associated with the use of the drug. Though a conclusion has not been reached yet, the FDA is now currently making a review of all published articles and plans to update the public upon finishing the evaluation.

Bibliography

AKESSON, K. 2003. New approaches to pharmacological treatment of osteoporosis.
Retrieved from http://www.who.int/bulletin/volumes/81/9/Akesson.pdf

CHESTNUT III, C.H., SKAG, A., CHRISTIANSEN, C., ET AL. 2004. Effects of oral Ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. Retrieved from
http://onlinelibrary.wiley.com/doi/10.1359/JBMR.040325/full

LALLA, S., HOTHORN, L.A., HAAQ, N., ET AL. 1998. Lifelong administration of high doses of ibandronate increases bone mass and maintains bone quality of lumbar vertebrae in rats. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/9666930

MONIER-FAUGERE, M.C., FRIEDLER, R.M., BAUSS, F., ET AL. 1993. A new bisphosphonate, BM 21.0955, prevents bone loss associated with cessation of ovarian function in experimental dogs. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/8266826

MULLER, R., HANNAN, M., SMITH, S.Y., ET AL. 2004. Intermittent ibandronate preserves bone quality and bone strength in the lumbar spine after 16 months of treatment in the ovariectomized cynomolgus monkey. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/15476578

MUNDY, G.R. 1989. Calcium homeostasis: Hypercalcemia and hypocalcemia. London: Martin Dunitz

NATIONAL OSTEOPOROSIS FOUNDATION. 2002. Prevalence report. Retrieved from
http://www.nof.org/advocacy/resources/prevalencereport

RALSTON, S.H., THI?BAUD D., HERRMANN, Z., ET AL. 1997. Dose-response study of ibandronate in the treatment of cancer-associated hypercalcemia. Br J Cancer 1997;75:295-300

RAVN, P., CLEMMESEN, B., RIIS, B.J., ET AL. 1996. The effect on bone mass and bone markers of different doses of ibandronate: a new bisphosphonate for prevention and treatment of postmenopausal osteoporosis: a 1-year, randomized, double-blind, placebo-controlled dose-finding study. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/8922653

SHIMMER, R.C., BAUSS, F. 2003. Effect of daily and intermittent use of ibandronate on bone mass and bone turnover in postmenopausal osteoporosis: a review of three phase II studies. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/12637110

SMITH, S.Y., RECKER, R.R., HANNAN, M., ET AL. 2003. Intermittent intravenous administration of the bisphosphonate ibandronate prevents bone loss and maintains bone strength and quality in ovariectomized cynomolgus monkeys. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/12584035

US FOOD AND DRUGS ADMINISTRATION. 2011. Highlights of prescribing information: Boniva. Retrieved from
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf

VAN BEEK, E.R., COHEN, L.H., LEROY, I.M., ET AL. 2003. Differentiating the mechanisms of antiresorptive action of nitrogen containing bisphosphonates. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/14623056

WUSTER, C., SCHOTER, K.H., THIEBAUD, D., ET AL. 1993. Metylthylpentylaminopropylidenebisphosphonate: a new potent and safe bisphosphonate for the treatment of cancer-associated hypercalcemia. Bone Miner; 22:77-85

WORLD HEALTH ORGANIZATION. 1999. Osteoporosis: Both health organizations and individuals must act now to avoid an impending epidemic. Retrieved from
http://www.who.int/inf-pr-1999/en/pr99-58.html


 

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