What is Aclasta?
Aclasta is a solution for infusion (drip into a vein) containing the active substance zoledronic acid.
What is Aclasta used for?
Aclasta is used to treat osteoporosis (a disease that makes bones fragile) in post-menopausal women and in men. It is used in patients at risk of fractures (broken bones), even in those who have recently suffered a hip fracture in a minor traumatic episode such as a fall, and in patients whose osteoporosis is associated with long-term treatment term with glucocorticoids (a type of steroid).
Aclasta is also used in the treatment of Paget's bone disease in adults, a disease in which the normal process of bone growth has changed.
The medicine can only be obtained with a prescription.
How is Aclasta used?
Aclasta is given as an infusion lasting at least 15 minutes. This can be repeated once a year in patients being treated for osteoporosis. Patients who have suffered an Aclasta hip fracture should be given at least two weeks after the fracture repair operation. For Paget's disease, only an infusion of Aclasta is usually performed, but additional infusions can be considered in case of relapse. The effects of each infusion last for at least a year.
Before and after treatment the amount of fluids present in patients must be adequate, and they must also receive adequate amounts of vitamin D and calcium supplements. The use of paracetamol or ibuprofen (anti-inflammatory medicines) shortly after the administration of Aclasta can reduce symptoms such as fever, muscle pain, flu symptoms, joint pain and headache within 3 days after infusion. In the treatment of Paget's bone disease, Aclasta should only be used by a doctor experienced in treating the disease. Aclasta should not be used in patients with severe renal impairment. For all information, see the package leaflet.
How does Aclasta work?
Osteoporosis occurs when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to fractures. Osteoporosis becomes more common in postmenopausal women, when female estrogen hormone levels decrease. Osteoporosis can also occur in both sexes as an undesirable effect of glucocorticoid treatment. In Paget's disease the bones are consumed faster and when they grow back they are weaker than normal.
Zoledronic acid, the active ingredient in Aclasta, is a bisphosphonate. It blocks the action of osteoclasts, the body's cells responsible for breaking down the bone tissue. This leads to less bone loss with regard to osteoporosis and to less activity of Paget's disease. Zoledronic acid has also been authorized in the European Union (EU) as Zometa since March 2001 for the prevention of bone complications in bone cancer patients, and for the treatment of hypercalcaemia (high levels of calcium in the blood) caused by tumors.
How has Aclasta been studied?
Since zoledronic acid has been authorized in the EU in the form of Zometa for a number of years, the company presented the results of some of the studies carried out with Zometa, taken into consideration during the Aclasta examination.
For osteoporosis Aclasta has been studied in three main studies. In the first Aclasta study it was compared with placebo (a dummy treatment) in about 8, 000 elderly women with osteoporosis, looking at the number of spinal and hip fractures in the over three years. In the second study, Aclasta was compared with placebo in 2, 127 men and women with osteoporosis and who had recently suffered a hip fracture, observing the number of fractures over five years. of Aclasta was compared with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, observing the change in bone density in the spine over a year. In these studies patients were allowed to take other medicines for osteoporosis, but not other bisphosphonates.
Regarding Paget's disease, Aclasta was compared with risedronate in a total of 357 adult patients in two studies lasting six months. Patients were treated either with an infusion of Aclasta or with a once-a-day dose of risedronate for two months. The main measure of effectiveness was the number of patients who responded to treatment, defined as the return of serum alkaline phosphatase (an enzyme involved in bone decomposition) in the blood to normal or in any case to reduce by at least three quarters of the excess of serum alkaline phosphatase compared to normal.
What benefit has Aclasta shown during the studies?
Concerning osteoporosis, Aclasta was more effective than the comparator medicines. In the study of elderly women, the risk of fractures to the spine was reduced by 70% in patients who were given Aclasta (without other medicines for osteoporosis ) over 3 years compared to those given a placebo. There was a 41% reduction in the risk of hip fractures, comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking a placebo. In the study on men and women with fractures to 'hip, 9% of the patients who received Aclasta suffered a fracture (92 of 1 065), compared to 13% of the patients who received placebo (139 of 1 062). Finally, in patients receiving glucocorticoids, Aclasta was more effective than risedronate in increasing the bone density of the spine over a year of treatment.
In Paget's disease, Aclasta was more effective than risedronate. After six months, approximately 96% of patients responded to treatment in the two studies, compared with around 74% of patients who received risedronate.
What are the risks associated with Aclasta?
Most of the side effects associated with Aclasta tend to occur in the first three days after the infusion, becoming less common with repeat infusions. The most common side effect with Aclasta (seen in more than 1 patient in 10) is fever. For the full list of all side effects reported with Aclasta, see the Package Leaflet.
Aclasta should not be used in people who may be hypersensitive (allergic) to zoledronic acid, other bisphosphonates or any of the other ingredients. Aclasta should not be used in patients with hypocalcaemia (low calcium levels in the blood) or in women who are pregnant or breast-feeding.
Why has Aclasta been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aclasta's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Aclasta
On 15 April 2005, the European Commission granted Aclasta a marketing authorization valid for the whole Union to Novartis Europharm Limited. After five years, the marketing authorization was renewed for a further five years.
The full EPAR for Aclasta can be found here. For more information on treatment with Aclasta, read the package leaflet (included with EPAR).
Last update of this summary: 04-2010.
