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ALENDRONATE

(brend name: Fosamax)
Pharmacological category: bone resorption inhibitor
Reviews

Alendronate

J Periodontol. 2004 Dec;75(12):1579-85.
Effect of alendronate on periodontal disease in postmenopausal women: a randomized placebo-controlled trial.
Rocha ML, Malacara JM, Sanchez-Marin FJ, Vazquez de la Torre CJ, Fajardo ME.
Institute of Medical Research, University of Guanajuato, Leon, Mexico.

BACKGROUND: We investigated the effect of oral alendronate (ALN) treatment on radiological and clinical measurements of periodontal disease in postmenopausal women without hormone replacement therapy. METHODS: We evaluated the effect of 6 months of ALN treatment in 40 postmenopausal women, 55 to 65 years old with established periodontal disease, in a controlled, double-masked, prospective study. Volunteers were paired by age and randomized to receive ALN (10 mg/day) or placebo for the study period. Periodontal mechanical treatment was carried out in both groups. At baseline and after treatment, clinical evaluation, hormone blood levels, distance from the crestal alveolar bone (CAB) to the cemento-enamel junction (CEJ), calcaneus bone mineral density (BMD), hormone levels, serum N-telopeptide (NTx), and bone-specific alkaline phosphatase (BSAP) were assessed. RESULTS: Periodontal disease conditions improved in both groups, but greater improvement in probing depth (-0.8 +/- 0.3 mm versus -0.4 +/- 0.4 mm, P = 0.02) and gingival bleeding (-0.3% +/- 0.13% versus -0.2% +/- 0.06%, P = 0.006) was found in the ALN treated group. Calcaneus BMD increased in the ALN treated group (68 +/- 47 mm3 versus -26 +/- 81 mm3, P = 0.0006). CAB-CEJ distance diminished in the ALN group (-0.4 +/- 0.40 mm versus 0.60 +/- 0.53 mm, P = 0.00008). Marginal reduction in both NTx and BSAP levels was found in the ALN group (-9.4 +/- 6.6 nmol versus -4.3 +/- 4.7 nmol bone collagen equivalents, P = 0.08, and -7.7 +/- 8.4 versus -1.5 +/- 5.0 U/l, P = 0.1, respectively). Hormone levels were unchanged after treatment. Similar improvement of calcaneus BMD and CAB-CEJ distance with ALN treatment was found in obese and non-obese women. CONCLUSION: ALN treatment improved periodontal disease and bone turnover in postmenopausal women.
Effect of alendronate on bone mineral density and bone turnover in Thai postmenopausal osteoporosis.
J Bone Miner Metab. 2003;21(6):421-7.
Chailurkit LO, Jongjaroenprasert W, Rungbunnapun S, Ongphiphadhanakul B, Sae-tung S, Rajatanavin R.
Department of Medicine, Ramathibodi Hospital, Mahidol University, Rama 6th Road, Bangkok, Thailand.

Alendronate has recently been approved for the prevention and treatment of postmenopausal osteoporosis, and its efficacy has been demonstrated in many Western countries. Our present study was performed to evaluate the effect of alendronate on bone mineral density (BMD) and its tolerability in Thais. Eighty postmenopausal women with osteoporosis participated in this study. After giving informed consent, the subjects were randomly allocated either 10 mg alendronate or placebo in a double-blind fashion. All patients received a supplement of 500 mg elemental calcium daily. BMD at the lumbar spine, femoral neck, and distal forearm was measured at baseline and 6 and 12 months after treatment. Biochemical markers of bone resorption were determined at baseline and 6 months after treatment. Baseline characteristics were similar in both alendronate- and placebo-treated groups. Ten subjects discontinued the study. Of 70 subjects, 32 received 10 mg alendronate daily and the remaining subjects received placebo. At 1 year, BMD in the alendronate-treated group had increased from baseline by 9.2%, 4.6%, and 3.1% at lumbar spine, femoral neck, and distal forearm, respectively. These percentages were greater than those in controls (4.1%, 0.6%, and 1.0%, respectively). Urinary N-terminal telopeptide (NTx)-I and serum C-terminal telopeptide (CTx)-I levels decreased in both groups after 6 months of treatment. However, more reduction was demonstrated in the alendronate-treated group (71.9% vs. 28.4%, P < 0.01, and 84.7% vs. 33.1%, P < 0.01, respectively). Compliance with treatment and drug tolerability were good in both alendronate and placebo groups. We concluded that treatment with alendronate 10 mg daily for Thai postmenopausal women with osteoporosis significantly increased BMD at all skeletal sites and reduced biochemical markers of bone resorption. It was well tolerated without any serious side effects.
Postgrad Med. 2003 Sep;114(3):22-8, 32
Hip fracture prevention. Drug therapies and lifestyle modifications that can reduce risk
Fiechtner JJ
Colleges of Human and Osteopathic Medicine, Michigan State University, East Lansing, USA

The annual number of hip fractures sustained worldwide is expected to increase dramatically as the population ages. Adequate calcium and vitamin D intake and exercise are fundamental to any program for bone loss prevention or osteoporosis treatment. Fall prevention programs, weight-bearing and resistance exercise, hip protector use, and calcium and vitamin D supplementation can reduce hip fracture risk. Among the available antiosteoporosis agents, the bisphosphonates risedronate and alendronate have produced the greatest reductions in hip fracture risk in postmenopausal women. Nasal calcitonin and raloxifene have not demonstrated significant reductions in nonvertebral or hip fracture risk. The role of parathyroid hormone (1-34) in the treatment of hip fractures remains uncertain until more experience is gained about its use and studies with sufficient statistical power are performed. Data indicate that bisphosphonates consistently reduce hip fracture risk in patients with osteoporosis, especially those with an existing vertebral fracture. In addition to pharmacologic intervention, adequate nonpharmacologic preventive strategies should be included to ensure maximal reduction in risk of hip fracture.

J Womens Health Gend Based Med 2002 Apr;11(3):211-24
Combination treatment of osteoporosis: a clinical review
Crandall C
Department of Medicine, UCLA School of Medicine, UCLA National Center of Excellence in Women's Health (U.S. Dept. of Health & Human Services), Iris Cantor-UCLA Women's Health Center, 90095-7023, USA

OBJECTIVE: Because of the limited efficacy of available agents and to limit toxicity, there is considerable interest in combination pharmacotherapy for osteoporosis. METHODS: A search was performed for randomized controlled trials in MEDLINE (1966-present) using the keywords osteoporosis treatment and combination. RESULTS: Twenty-four randomized controlled trials evaluated osteoporosis medications in combination. Study duration ranged from 1 to 4 years. No serious adverse events were definitively attributable to study drugs. Fracture reduction outcome is not shown for any combination regimen. The literature was mixed regarding bone density augmentation. Combinations of nandrolone decanoate plus calcitonin, calcitonin plus growth hormone (GH), or pamidronate plus GH may be contradictory or detrimental to bone mineral density (BMD). For postmenopausal osteoporosis or osteopenia, four combinations appear to increase hip and lumbar BMD: 10 mg alendronate with 0.625 mg conjugated equine estrogens (CEE), cyclic etidronate with 0.625mg CEE, 10 mg alendronate with 2 mg estradiol (E(2)), and tibolone with fluoride. For steroid-related osteoporosis, intermittent etidronate with fluoride increases lumbar BMD. CONCLUSIONS: The few trials including Food and Drug Administration (FDA)-approved medications suggest that 10 mg/day alendronate with estrogen (equivalent of 0.625 mg CEE daily) can increase BMD moreso than each medication given singly in postmenopausal osteoporotic women. Estrogen dose and type must be controlled in future trials. Long-term safety data are lacking. The utility of these combinations rests on whether bone density changes will translate into decreased fracture rates.

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Drug information

GENERIC NAME: alendronate
BRAND NAME: Fosamax


DRUG CLASS AND MECHANISM: Alendronate is in a class of medications used to strengthen bone. Bone is in a constant state of remodeling, whereby old bone is removed by cells called osteoclasts, and new bone is laid down by cells called osteoblasts. Alendronate inhibits bone removal by the osteoclasts.

PREPARATIONS: tablet: 10mg (daily); 70mg (weekly)

STORAGE: Store at room temperature, sealed container, avoid moisture.

PRESCRIBED FOR: Alendronate is used to treat osteoporosis (thinning of bone) in women after menopause. After menopause, there is an increased rate of bone loss (resorption). In these patients, alendronate has been shown to increase bone density while strengthening bone, and decrease the rate of bone fractures. Alendronate is also helpful in the treatment of Paget's disease of the bone. Paget's disease is characterized by a disorderly and accelerated remodeling of the bone, leading to bone weakness and pain.

DOSING: Since food, other medications, and vitamins can interfere with the absorption of alendronate, it should be taken at least 30 minutes before food, beverage, vitamins or medicines. In order to avoid chemical irritation of the esophagus (the tube that connects the mouth with the stomach), alendronate should be taken with a full glass of plain water first thing in the morning and never chewed or sucked. It should be avoided by patients with abnormalities of the esophagus which delay esophageal emptying, such as scarring (stricture) or poor motility (achalasia). Patients should also not lie down for 30 minutes after swallowing the tablets. Those patients who are unable to remain upright for at least 30 minutes after taking medication should avoid alendronate.

DRUG INTERACTIONS: The safety of alendronate in patients with significant kidney disease is not known. Therefore, it is not recommended for patients with significant kidney conditions. Since alendronate can lower blood calcium, low blood calcium levels are corrected prior to use. Calcium supplements, antacids and medications can interfere with the absorption of alendronate.

PREGNANCY: The safety and effectiveness of alendronate has not been established in children or women who are pregnant or nursing.

NURSING MOTHERS: The safety and effectiveness of alendronate has not been established in children or women who are pregnant or nursing.

SIDE EFFECTS: Alendronate is generally well tolerated. Side effects are infrequent and mild. Side effects include stomach pain or upset, constipation, diarrhea, muscle ache, and headache. Alendronate can irritate the esophagus to cause heartburn in patients who lie down flat after swallowing, thereby delaying passage of the medication to the stomach.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.
Also, you should read carefully important health information about this drug given here:


www.nlm.nih.gov

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FOSAMAX - GENERIC (generic - what is it?)
Substance: Alendronate

 
Dosage
Packing
Price
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10 mg
30 tab
USD 0.00
10 mg
60 tab
USD 53.00
10 mg
90 tab
USD 0.00
10 mg
180 tab
USD 83.00
70 mg
8 tab
USD 49.00
70 mg
16 tab
USD 79.00
70 mg
32 tab
USD 139.00
 

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