Most of the patients were postmenopausal women. The time to onset of symptoms varied from one day to several months after starting the drug. Discontinue use if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
Known risk factors for osteonecrosis of the jaw include invasive dental procedures e. The risk of ONJ may increase with duration of exposure to bisphosphonates.
For patients requiring invasive dental procedures, discontinuation of bisphosphonate treatment may reduce the risk for ONJ. Patients who develop osteonecrosis of the jaw while on bisphosphonate therapy should receive care by an oral surgeon.
In these patients, extensive dental surgery to treat ONJ may exacerbate the condition. Atypical Subtrochanteric And Diaphyseal Femoral Fractures Atypical , low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.
Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with bisphosphonates. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs.
A number of reports note that patients were also receiving treatment with glucocorticoids e. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture.
Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Before initiating treatment, the gonadal hormonal status of both men and women should be ascertained and appropriate replacement considered. A bone mineral density measurement should be made at the initiation of therapy and repeated after 6 to 12 months of combined FOSAMAX and glucocorticoid treatment.
Osteoporosis Recommendations, Including Calcium And Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D, if daily dietary intake is inadequate.
Dosing Instructions Instruct patients that the expected benefits of FOSAMAX may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Instruct patients not to chew or suck on the tablet because of a potential for oropharyngeal ulceration. Instruct patients to swallow each tablet of FOSAMAX with a full glass of water ounces to facilitate delivery to the stomach and thus reduce the potential for esophageal irritation.
Instruct patients to drink at least 2 ounces a quarter of a cup of water after taking FOSAMAX oral solution, to facilitate gastric emptying. Instruct patients not to lie down for at least 30 minutes and until after their first food of the day.
Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Instruct patients that if they develop symptoms of esophageal disease such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn they should stop taking FOSAMAX and consult their physician. They should not take two doses on the same day but should return to taking one dose once a week, as originally scheduled on their chosen day.
These doses are equivalent to approximately 0. The relevance of this finding to humans is unknown. Alendronate was not genotoxic in the in vitro microbial mutagenesis assay with and without metabolic activation, in an in vitro mammalian cell mutagenesis assay, in an in vitro alkaline elution assay in rat hepatocytes, and in an in vivo chromosomal aberration assay in mice. In an in vitro chromosomal aberration assay in Chinese hamster ovary cells, however, alendronate gave equivocal results.
FOSAMAX should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years.
The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation , is directly related to the dose and duration of bisphosphonate use. There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy.
The impact of variables such as time between cessation of bisphosphonate therapy to conception , the particular bisphosphonate used, and the route of administration intravenous versus oral on the risk has not been studied.
Reproduction studies in rats showed decreased postimplantation survival and decreased body weight gain in normal pups at doses less than half of the recommended clinical dose.
Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at approximately 3 times the clinical dose in vertebral cervical , thoracic , and lumbar , skull, and sternebral bones.
No similar fetal effects were seen when pregnant rabbits were treated with doses approximately 10 times the clinical dose. Both total and ionized calcium decreased in pregnant rats at approximately 4 times the clinical dose resulting in delays and failures of delivery.
Protracted parturition due to maternal hypocalcemia occurred in rats at doses as low as one tenth the clinical dose when rats were treated from before mating through gestation. Maternotoxicity late pregnancy deaths also occurred in the female rats treated at approximately 4 times the clinical dose for varying periods of time ranging from treatment only during pre-mating to treatment only during early, middle, or late gestation; these deaths were lessened but not eliminated by cessation of treatment.
Calcium supplementation either in the drinking water or by minipump could not ameliorate the hypocalcemia or prevent maternal and neonatal deaths due to delays in delivery; intravenous calcium supplementation prevented maternal, but not fetal deaths. Nursing Mothers It is not known whether alendronate is excreted in human milk.
The safety and efficacy of FOSAMAX were examined in a randomized, double-blind, placebocontrolled two-year study of pediatric patients, aged years, with severe osteogenesis imperfecta OI. The mean baseline lumbar spine BMD Z-score of the patients was In FOSAMAX-treated patients, bone histomorphometry data obtained at Month 24 demonstrated decreased bone turnover and delayed mineralization time; however, there were no mineralization defects.
The oral bioavailability in children was similar to that observed in adults. During the month treatment period, vomiting was observed in 32 of These events, lasting no more than 2 to 3 days and responding to acetaminophen , are consistent with an acute-phase response that has been reported in patients receiving bisphosphonates, including FOSAMAX.
No overall differences in efficacy or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Hepatic Impairment As there is evidence that alendronate is not metabolized or excreted in the bile , no studies were conducted in patients with hepatic impairment. Hypocalcemia , hypophosphatemia , and upper gastrointestinal adverse events, such as upset stomach, heartburn , esophagitis , gastritis , or ulcer, may result from oral overdosage.
Milk or antacids should be given to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial. At the cellular level, alendronate shows preferential localization to sites of bone resorption , specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption.
Alendronate does not interfere with osteoclast recruitment or attachment, but it does inhibit osteoclast activity. Studies in mice on the localization of radioactive [3H]alendronate in bone showed about fold higher uptake on osteoclast surfaces than on osteoblast surfaces.
Bones examined 6 and 49 days after [3H]alendronate administration in rats and mice, respectively, showed that normal bone was formed on top of the alendronate, which was incorporated inside the matrix. While incorporated in bone matrix, alendronate is not pharmacologically active. Thus, alendronate must be continuously administered to suppress osteoclasts on newly formed resorption surfaces.
Histomorphometry in baboons and rats showed that alendronate treatment reduces bone turnover i. In addition, bone formation exceeds bone resorption at these remodeling sites, leading to progressive gains in bone mass.
Pharmacodynamics Alendronate is a bisphosphonate that binds to bone hydroxyapatite and specifically inhibits the activity of osteoclasts, the bone-resorbing cells. Do not take these for at least 30 minutes preferably 1 to 2 hours after taking alendronate. Take this medication regularly to get the most benefit from it. Remember to take it on the same day each week. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.
Quick GuideWhat Is Osteoporosis? Stomach pain , constipation , diarrhea , gas , or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: This medication may infrequently cause serious irritation and ulcers of the esophagus.
If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US -Call your doctor for medical advice about side effects.
In Canada - Call your doctor for medical advice about side effects.
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