What is Adrovance?
Adrovance is a medicine that contains two active substances: alendronate sodium trihydrate and colecalciferol (vitamin D3). It is available as white tablets (capsule-shaped: 70 mg alendronate sodium trihydrate and 2,800 international units [IU] of colecalciferol; rectangular: 70 mg of alendronate sodium trihydrate and 5,600 IU of colecalciferol).
What is Adrovance used for?
Adrovance (containing 2,800 IU or 5,600 IU cholecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have gone through the menopause and who are at risk of vitamin D deficiency. mg / 5,600 IU is indicated in patients not taking vitamin D supplements. Adrovance reduces the risk of fractures of the vertebrae and hip.
The medicine can only be obtained with a prescription.
How is Adrovance used?
The recommended dose of Adrovance is one tablet per week. The medicine is indicated for long-term therapies.
The tablet should be swallowed with a full glass of water (but not mineral) at least 30 minutes before the ingestion of any food, drink or other drug (including antacids, calcium supplements and vitamins). To avoid irritating the esophagus, the patient should not go to bed before the end of the first meal of the day, which should take place at least 30 minutes after taking the tablet. The tablet should be swallowed whole and not crushed, chewed or dissolved in the mouth.
If the normal diet does not ensure sufficient calcium intake, the patient will need to take calcium supplements. For further information, see the package leaflet.
How does Adrovance work?
Osteoporosis occurs when there is insufficient bone turnover that decomposes naturally. Bones become progressively thinner and more fragile, therefore they are more prone to fractures. Osteoporosis is more common in women who have passed menopause due to of the lowering of the levels of female hormones, estrogen, which allow to preserve the bones.
Adrovance contains two active substances: alendronate and colecalciferol (vitamin D3). Alendronate is a bisphosphonate used in the treatment of osteoporosis since the mid-1990s which acts by inhibiting the action of osteoclasts, the cells that are involved in the breakdown of bone tissue. This inhibitory action reduces the loss of bone tissue. Vitamin D3 is a nutrient contained in some foods but also produced by the skin when exposed to sunlight. Vitamin D3, as well as other forms of vitamin D, is necessary for the absorption of calcium and the normal formation of bone tissue. Since one of the causes of osteoporosis is insufficient intake of vitamin D3 produced by exposure to sunlight, Adrovance contains vitamin D3.
How has Adrovance been studied?
Since alendronate and vitamin D3 are already used separately in other medicines authorized in the European Union (EU), the pharmaceutical company presented data from previous studies and data published in the scientific literature for postmenopausal women taking alendronate and vitamin D in separate tablets.
To support the combination of alendronate and vitamin D3 in the same tablet, the pharmaceutical company also conducted a study of 717 patients with osteoporosis, including 682 postmenopausal women with osteoporosis, to demonstrate Adrovance's ability to raise vitamin D levels. Patients were given Adrovance 70 mg / 2 800 IU or alendronate alone once weekly. The main measure of effectiveness was the decrease in the number of patients with vitamin D deficiency after 15 weeks. This study was extended in 652 patients for an additional 24 weeks to compare the effects on continuing therapy with Adrovance 70 mg / 2 800 IU alone (alone) or with the addition of an additional 2 800 IU of vitamin D3 (equivalent to the use of Adrovance 70 mg / 5 600 IU).
What benefit has Adrovance shown during the studies?
Information presented by the company from previous studies and published literature showed that the dose of alendronate contained in Adrovance is the same as that needed to avoid bone loss.
Complementary studies showed that adding vitamin D3 to the same tablet containing alendronate could raise vitamin D levels: after 15 weeks, fewer patients reported low vitamin D levels when treated with Adrovance 70 mg / 2,800 IU ( 11%) compared to those treated with alendronate alone (32%). In the extension study, although the same number of patients taking Adrovance 70 mg / 2 800 IU and Adrovance 70 mg / 5 600 IU had low levels of vitamin D, patients taking Adrovance 70 mg / 5 600 IU had a greater increase in vitamin D levels over the 24-week study duration.
What is the risk associated with Adrovance?
The most common side effects seen with Adrovance (seen in 1 to 10 patients in 100) are headache, abdominal pain (stomach pain), dyspepsia (indigestion), constipation, diarrhea, flatulence, ulcers in the esophagus, dysphagia (difficulty swallowing), abdominal distension (swollen belly), acid regurgitation and musculoskeletal pain (bones, muscles, joints). For the full list of side effects reported with Adrovance, see the package leaflet.
Adrovance should not be used in patients who may be hypersensitive (allergic) to alendronate, vitamin D3 or any of the other ingredients. Adrovance should also not be used in the presence of abnormal esophagus, in patients with hypocalcaemia (calcium deficiency). and in patients unable to stand or sit upright for at least 30 minutes.
Why has Adrovance been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Adrovance's benefits are greater than its risks for the treatment of osteoporosis in postmenopausal women at risk of vitamin D deficiency. "Marketing Authorization" for Adrovance.
Other information about Adrovance:
On January 4, 2007, the European Commission granted Merck Sharp & Dohme Ltd. an EU-wide "Marketing Authorization" for Adrovance.
For the full version of the Adrovance EPAR click here.
Last update of this summary: 07-2009.
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