Skelid – A fast and effective treatment of Paget’s disease.

What is Paget’s Disease?

Paget’s Disease, or to give it it’s full title ‘Paget’s Disease of the bone’ (also known as Osteitis Deformans and not to be confused with the unrelated skin disease that also bears the Paget name) is a chronic, potentially debilitating bone disease that is characterized by the formation of enlarged and deformed bones.

The disease was first described back in 1877 by the British surgeon Sir James Paget, from whom the condition takes its name. Whilst not as well known as the bone disease osteoporosis, Paget’s Disease is in fact fairly common. For example, it is estimated that it affects around 3-4% of the US population over the age of 50, increasing to 10% in people aged over 80. Indeed, as far as the prevalence of bone disease is concerned, Paget’s Disease is second only to osteoporosis and, unlike osteoporosis, it is slightly more common in men than in women.

Bones become enlarged and weakened as a result of Paget’s Disease because the disease interferes with the bone remodelling processes. Our bones are not static structures - bone is a dynamic tissue and as such our bones are constantly being reformed, reshaped and rebuilt. This process of removing old bone and laying down new bone is called bone remodelling and is carried out by specialized cells known as osteoclasts and osteoblasts. These cells work continuously to form new bone (osteoblasts) and remove and reabsorb old bone (osteoclasts).

A delicate balance exists between the activities of osteoclasts and osteoblasts to achieve normal bone metabolism. However, when someone suffers from Paget’s Disease this intricate balance is disturbed and normal bone metabolism is interfered with. Bone remodelling occurs at an excessive rate with both an increase in the amount of bone broken down and digested by osteoclasts and an increase in the formation of new bone by osteoblasts. This new bone is irregular in formation. In addition, normal bone marrow is replaced with blood vessels and fibrous tissue. All this activity results in bones that are weakened, soft, unstable and abnormally enlarged. Although any part of the skeleton can be affected, the most common sites include the skull, spine, pelvis, thigh bone, shin and the bone of the upper arm.

Despite the seemingly catastrophic effects, the vast majority of people suffering from Paget’s Disease are symptomless and may remain that way for many years. The development of symptoms only gradually becomes apparent over a long period of time. Indeed, often the discovery of the condition is accidental - for example when someone has an X-Ray for a totally unrelated problem. However, over time a sufferer’s bones can become enlarged, deformed, painful, weak and prone to breaking. Pain and muscle weakness can also develop if the enlarged and deformed bones put pressure on surrounding nerves. Unfortunately, for a very small minority of sufferers, the symptoms can quickly become severe and debilitating.

Symptoms of Paget’s Disease may include:

• Painful, aching bones
• Aches and pains that are more acute during the night
• Joint stiffness
• Bones that appear bent or thickened - if it occurs in the leg bones, legs may appear bowed
• The affected site is significantly warmer than the rest of the body
• Bone fractures
• Constant fatigue

Apart from the more obvious complication of suffering from bone fractures, Paget’s Disease can lead to other complications that can be extremely debilitating. For example, Paget’s Disease can result in:

• The development of osteoarthritis in joints near to affected bones
• Deafness as a result of pressure on auditory nerves
• Numbness or paralysis if vertebrae are affected and they deteriorate to such an extent that they pinch nerves in the spinal cord
• Cancer of the affected bone tissue ( this occurs in around 1% of cases)

If a sufferer already has heart disease then Paget’s Disease may trigger heart failure. This is because the disease leads to an increased workload on the heart because of the increased number of blood vessels in affected bones which results in an increase in blood flow through the bones.

What causes Paget’s Disease?

As yet, the cause of Paget’s Disease is not fully understood. Genetic and environmental factors may play a significant role. It has been suggested that if someone has a genetic predisposition to the disorder (there is a family history of the disease in around 30% of cases) and they become infected with an unidentified virus, the disease may then be triggered. Although the underlying cause may not be understood, it does appear that the following are risk factors for developing the condition:

• Increasing age
• Race - people with Anglo-Celtic backgrounds appear to be more susceptible
• Genetics

How can Skelid help someone with Paget’s Disease?

The active ingredient in Skelid is Tiludronate Disodium (the disodium salt of Tiludronic Acid). It belongs to a class of drugs known as bisphosphonates which act to prevent the loss of bone mass. Although bisphosphonates were developed in the 19th century, they were not investigated in relation to bone metabolism disorders until the 1960s. Skelid is a relatively new bisphosphonates - it did not receive US approval until March 1997.

Bisphosphonates work to reduce the turnover of bone by inhibiting the digestion of bone by osteoclasts. Skelid causes osteoclasts to initiate programmed cell death (apoptosis - in effect a form of cell suicide). As the numbers of osteoclasts decline as a result of apoptosis, there is a concomitant reduction in the resorption of bone. By slowing down bone resorption in this way and by allowing new bone to form, Skelid effectively reduces bone turnover. This helps to lessen bone deformity and keeps bones strong and less likely to break.

How effective is Skelid in the treatment of Paget’s Disease?

Skelid has been proven to be a strong inhibitor of bone resorption. What’s more, Skelid controls abnormal bone growth without interfering with the normal process of bone formation. And Skelid is relatively quick acting - it is effective in a three month dosage regime, which might not seem particularly quick until you compare it with other oral bisphosphonates that normally employ a 6 month regime!

The reader should also note the following:

• Paget’s Disease is incurable - Skelid acts to control its symptoms, not to cure it
• Vitamin D and Calcium are also required for strong bones. If your diet alone does not provide you with adequate supplies, you may need to take additional dietary supplements
• Calcium density in bones can also be increased by weight bearing exercise

Dosage

You should take a single 200mg to 400mg oral dose daily of Skelid. This dose should be taken with 6 to 8 ounces of plain water only (no other form of drink should be substituted for plain water).

Skelid is only effective if taken on an empty stomach. Therefore do not take Skelid within 2 hours of eating or drinking (either before or after). This is because food and some drinks (particularly milk) can interfere with the absorption of the medicine from the gut which will make Skelid less effective.

It is important to tell your doctor of any medicines that you taking (including prescription, over the counter and herbal ones and any supplements) before you start taking Skelid or that you propose to take while receiving Skelid therapy. In particular, calcium or iron supplements, vitamins, antacids (indigestion remedies) containing calcium, aspirin, or indomethacin may interfere with the absorption of Skelid. Do not take Skelid within 2 hours of these medicines.

Do not take an antacid that has aluminum or magnesium in it within 1 hour before or 2 hours after taking Skelid.

You should continue to take Skelid as prescribed even if you feel well. If you do miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.

As mentioned above the dosage regime should last for a period of 3 months. If your doctor decides re-treatment is necessary after this time because the disease has flared up again, then Skelid should only be re-started after you have had an interval of at least six months without taking it.

Side Effects

All medicines carry with them the possibility of side effects. Fortunately, Skelid appears to be very well tolerated and adverse side effects are usually mild in nature and do not lead to discontinuation of the therapy. Set out below are some of the more common side effects associated with Skelid but it is important to remember that just because a side effect is listed it does not mean that you will experience it:

• Nausea, vomiting, diarrhoea, abdominal pain and dyspepsia
• Abnormal skin sensations and rashes
• Stuffy nose
• Dizziness, headaches and feeling weak If you should experience any of the above side effects and they become bothersome or persistant, consult your doctor.
  • You are allergic to any ingredient in Skelid
  
  
  • You have severe kidney problems or oesophagus problems, including difficulty swallowing or a narrow or blocked oesophagus
  
  
  • You are unable to stand or sit for at least 30 minutes
  
  
  • You have Juvenile Paget’s Disease
  
  
  • You have low levels of calcium in the blood (hypocalcaemia) or a Vitamin D deficiency Do not drink alcohol, smoke, or use other tobacco products while taking Skelid.
  
  
  • Pregnancy - the safety of Skelid for use during pregnancy has not been established and therefore it should not be taken by women who are pregnant or who are planning a pregnancy. If you do become pregnant whilst taking Skelid, contact your doctor.
  
  
  • Breast feeding - it is not known if Skelid passes into breast milk. Therefore it should not be used by women who are breastfeeding and you should seek advice from your doctor.
  
  
  • Your kidney function should be monitored during treatment with Skelid.

Skelid may also cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. You should not drive or perform other possibly unsafe tasks until you know how you react to it.

In the unlikely event that you should suffer a severe side effect such as a severe allergic reaction, chest pain, difficulty in swallowing, red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain; severe or persistent stomach pain; swelling of the hands or feet or vision changes you should seek immediate medical attention.

Bisphosphonates such as Skelid have also been associated with a rare jaw bone problem called osteonecrosis of the jaw. Your risk may be greater if you have cancer, poor dental hygiene, or certain other conditions (e.g. anaemia, blood clotting problems, infections, dental problems). Your risk may also be greater if you taking certain medicines or receiving certain therapies (e.g. chemotherapy, corticosteroids, radiation). Your doctor may want you to have a dental examination and, if necessary, have any dental work carried out before you start treatment with Skelid. It is really important that you look after your mouth and teeth as much as possible while you are taking Skelid and any invasive dental procedures such as tooth extraction or surgery should be avoided if possible. If you need to see a dentist during treatment, make sure they know you are using Skelid.

Warnings

Do not use Skelid if: