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What is the latest research on Fosamax? What is Fosamax used for? Side Effects for Fosamax
Fosamax helps reduce bone loss from Osteoporosis. Caucasian and Asian women are at greater risk.
Menopause is a key factor. Food disorders such as anexoria and bulumia may create the need for Fosamax.
Intense physical exercise may also create the need for Fosamax.
From Merck's website on Fosamax
"You should not use FOSAMAX if you have certain disorders of the esophagus (the tube connecting the mouth with the stomach), are unable to stand or sit upright for 30 minutes, have severe kidney disease, low blood calcium, or are allergic to FOSAMAX. Before use, talk to your doctor if you have stomach or digestive problems. Stop taking FOSAMAX and tell your doctor if you develop new or worsening heartburn, difficult or painful swallowing, or chest pain because these may be signs of serious upper digestive problems which can include irritation, inflammation, or ulceration of the esophagus. (See Patient Product Information for more details.) Digestive side effects in studies were generally mild and included stomach pain, indigestion/heartburn, or nausea" The following are the latest research abstracts on Fosamax:
Isr Med Assoc J. 2003 Dec;5(12):859-62. :
Compliance of osteoporotic patients with different treatment regimens.
Segal E, Tamir A, Ish-Shalom S.
Metabolic Bone Diseases Unit, Rambam Medical Center, Haifa, Israel.
BACKGROUND: The treatment of osteoporosis among postmenopausal women represents a major public health challenge since long-term therapy is needed to prevent fractures and chronic disability. OBJECTIVES: To assess compliance with osteoporosis drug therapy among Israeli postmenopausal women treated with either a bisphosphonate (alendronate) or a selective estrogen receptor modulator (raloxifene); to identify factors affecting compliance among these patients; and to compare adherence to the treatment in these two groups. METHODS: Our study included 178 consecutive patients aged 67.41 +/- 8.52 years who were treated for osteoporosis with alendronate or raloxifene in the Metabolic Bone Diseases Unit. All the patients received supplementation with calcium carbonate 1,500 mg and 600 IU vitamin D daily. Compliance was assessed at a clinic visit 6 months after starting therapy. RESULTS: The dropout rate was 23% (41 patients): 20 patients (31%) in the raloxifene group and 21 (18%) in the alendronate group (P = 0.0041). The main reasons for dropout were side effects and/or noncompliance, 16 and 24 patients (39% and 58.53%) respectively. The most frequent side effect was abdominal pain in 9 patients (42.8%) who discontinued alendronate use. The reasons for non-compliance were a fear of side effects and high drug price in 6 (30%) and 4 (20%) patients respectively in the raloxifene group, and inconvenience caused by medication use in 3 patients (14.3%) in the alendronate group. Logistic regression analysis of factors that may influence compliance included age, previous fractures, family history of osteoporosis, bone density T-score less than -2.5, and presence and number of concomitant diseases. Age was the only statistically significant parameter in this model: 67.8 +/- 8.8 in non-compliant versus 64.11 +/- 7.4 in compliant patients (P = 0.029). CONCLUSION: At least 20% of the patients discontinued chronic treatment for osteoporosis during the initial 6 months of therapy. The main reasons were gastrointestinal side effects in the alendronate group and fear of side effects and high drug price in the raloxifene group. Older age was the only statistically significant factor influencing compliance.
Forteo
Issues Emerg Health Technol. 2003 Nov;(51):1-4. :
Treating osteoporosis with teriparatide: many unknowns?
Shukla VK.
In the US, teriparatide is indicated for the treatment of patients with osteoporosis who are "at high risk for fracture." Although placebo-controlled trials show that teriparatide can reduce fractures, there is little information on its efficacy compared to available alternatives. In the US, the Food and Drug Administration highlighted concerns about teriparatide's carcinogenic effects in rats. Company-sponsored studies have been voluntarily stopped.
Arch Intern Med. 2003 Oct 13;163(18):2237-46. :
Aging bone and osteoporosis: strategies for preventing fractures in the elderly.
Ettinger MP.
Regional Osteoporosis Center of South Florida and Radiant Research Stuart Florida, Stuart 34996, USA.
markettinger@radiantresearch.comAs the older population increases, the incidence of osteoporotic fractures is expected to dramatically rise during the next few decades. Older patients are much more susceptible to fracture at any given bone mineral density (BMD) than are younger patients because of various factors, including the quality of aging bone, which involves more than BMD. Suppression of increased bone turnover by antiresorptive therapies, even with only small changes in BMD, can reduce fracture risk, especially in the lumbar spine. Bisphosphonate treatment can significantly reduce vertebral and nonvertebral fractures, including hip fractures, even in the very elderly. Prospective analyses show that risedronate therapy consistently and significantly reduces the risk of new morphometric vertebral fractures after 1 year in postmenopausal women. Post hoc analyses report significant reductions in the risk of 1 new clinical vertebral fracture after 6 months of risedronate therapy and after 1 year of alendronate therapy. Oral raloxifene therapy and salmon calcitonin nasal spray therapy have been shown to reduce the risk of vertebral fracture after 3 and 5 years, respectively, and post hoc data show a significant reduction in clinical vertebral fracture risk at 1 year with raloxifene use. However, neither raloxifene therapy nor calcitonin therapy reduce the risk of nonvertebral and hip fractures at currently approved doses. Bisphosphonates have been shown to be safe and efficacious with 7 years' risedronate sodium and 10 years' alendronate sodium data published, and bisphosphonates reduce bone turnover and increase BMD to a greater degree than raloxifene and calcitonin, which may partly account for their nonvertebral and hip fracture reduction effect. Therefore, bisphosphonate therapy with risedronate or alendronate should be considered in patients with low BMD at the hip and in older patients with osteoporosis and osteopenia, particularly those with an existing fracture.
Am J Gastroenterol. 2003 Oct;98(10):2268-74. :
Alendronate is more effective than etidronate for increasing bone mass in osteopenic patients with primary biliary cirrhosis.
Guanabens N, Pares A, Ros I, Alvarez L, Pons F, Caballeria L, Monegal A, Martinez de Osaba MJ, Roca M, Peris P, Rodes J.
Metabolic Bone Diseases Unit, Hospital Clinic, Institut d'Investigacions Mediques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
OBJECTIVES: Osteopenia increases the morbidity of primary biliary cirrhosis (PBC). In this study, we have compared two bisphosphonates, alendronate and cyclical etidronate, that inhibit osteoclast-mediated bone resorption and have examined their effects on bone mass in patients with this disease. METHODS: A total of 32 women with PBC were randomly assigned to receive alendronate (10 mg/day) or etidronate (400 mg/day) for 14 days every 3 months. Bone mineral density of the lumbar spine and proximal femur were measured initially and every 6 months. Bone fractures and markers of bone mineral metabolism were also evaluated. RESULTS: Sixteen patients were allocated to each group, which were comparable with respect to the severity of PBC and osteopenia. Thirteen patients in each group completed the 2-yr trial. Both treatments increased bone mineral density after 2 yr, although the increase at the lumbar spine and at the proximal femur was significantly higher in patients receiving alendronate than in patients on etidronate. This higher effect of alendronate paralleled with changes in the biochemical markers of bone turnover. No patient developed new vertebral fractures, but new peripheral fractures were detected in two patients on alendronate and in one on etidronate. There were no serious adverse effects. Neither treatment impaired liver function or cholestasis. CONCLUSIONS: Alendronate effectively increases bone mass and has greater antiresorptive power than etidronate in patients with primary biliary cirrhosis, and is associated with minor or no side effects.
1: N Engl J Med. 2003 Sep 25;349(13):1207-15. Epub 2003 Sep 20. :
Comment in:
N Engl J Med. 2003 Sep 25;349(13):1277-9.
The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis.
Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators.
Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA 94105, USA.
dblack@psg.ucsf.eduBACKGROUND: Parathyroid hormone increases bone strength primarily by stimulating bone formation, whereas antiresorptive drugs reduce bone resorption. We conducted a randomized, double-blind clinical study of parathyroid hormone and alendronate to test the hypothesis that the concurrent administration of the two agents would increase bone density more than the use of either one alone. METHODS: A total of 238 postmenopausal women (who were not using bisphosphonates) with low bone mineral density at the hip or spine (a T score of less than -2.5, or a T score of less than -2.0 with an additional risk factor for osteoporosis) were randomly assigned to daily treatment with parathyroid hormone (1-84) (100 microg; 119 women), alendronate (10 mg; 60 women), or both (59 women) and were followed for 12 months. Bone mineral density at the spine and hip was assessed by dual-energy x-ray absorptiometry and quantitative computed tomography. Markers of bone turnover were measured in fasting blood samples. RESULTS: The bone mineral density at the spine increased in all the treatment groups, and there was no significant difference in the increase between the parathyroid hormone group and the combination-therapy group. The volumetric density of the trabecular bone at the spine increased substantially in all groups, but the increase in the parathyroid hormone group was about twice that found in either of the other groups. Bone formation increased markedly in the parathyroid hormone group but not in the combination-therapy group. Bone resorption decreased in the combination-therapy group and the alendronate group. CONCLUSIONS: There was no evidence of synergy between parathyroid hormone and alendronate. Changes in the volumetric density of trabecular bone, the cortical volume at the hip, and levels of markers of bone turnover suggest that the concurrent use of alendronate may reduce the anabolic effects of parathyroid hormone. Longer-term studies of fractures are needed to determine whether and how antiresorptive drugs can be optimally used in conjunction with parathyroid hormone therapy. Copyright 2003 Massachusetts Medical Society
1: N Engl J Med. 2003 Sep 25;349(13):1216-26. Epub 2003 Sep 20. :
Comment in:
N Engl J Med. 2003 Sep 25;349(13):1277-9.
The effects of parathyroid hormone, alendronate, or both in men with osteoporosis.
Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM.
Endocrine Unit, Department of Medicine, Massachusetts General Hospital, Boston 02114, USA.
jfinkelstein@partners.orgBACKGROUND: Because parathyroid hormone increases both bone formation and bone resorption, it is possible that combining parathyroid hormone with an antiresorptive agent will enhance its effect on bone mineral density. METHODS: We randomly assigned 83 men who were 46 to 85 years of age and had low bone density to receive alendronate (10 mg daily; 28 men), parathyroid hormone (40 microg subcutaneously daily; 27 men), or both (28 men). Alendronate therapy was given for 30 months; parathyroid hormone therapy was begun at month 6. The bone mineral density of the lumbar spine, proximal femur, radial shaft, and total body was measured every six months with the use of dual-energy x-ray absorptiometry. Trabecular bone mineral density of the lumbar spine was measured at base line and month 30 by means of quantitative computed tomography. Serum alkaline phosphatase levels were measured every six months. The primary end point was the rate of change in the bone mineral density at the posteroanterior spine. RESULTS: The bone mineral density at the lumbar spine increased significantly more in men treated with parathyroid hormone alone than in those in the other groups (P<0.001 for both comparisons). The bone mineral density at the femoral neck increased significantly more in the parathyroid hormone group than in the alendronate group (P<0.001) or the combination-therapy group (P=0.01). The bone mineral density of the lumbar spine increased significantly more in the combination-therapy group than in the alendronate group (P<0.001). At 12 months, changes in the serum alkaline phosphatase level were significantly greater in the parathyroid hormone group than in the alendronate group or the combination-therapy group (P<0.001 for both comparisons). CONCLUSIONS: Alendronate impairs the ability of parathyroid hormone to increase the bone mineral density at the lumbar spine and the femoral neck in men. This effect may be attributable to an attenuation of parathyroid hormone-induced stimulation of bone formation by alendronate. Copyright 2003 Massachusetts Medical Society
Fertil Steril. 2003 Sep;80(3):536-40. :
Effect of daily hormone therapy and alendronate use on bone mineral density in postmenopausal women.
Davas I, Altintas A, Yoldemir T, Varolan A, Yazgan A, Baksu B.
Second Obstetrics and Gynecology Clinic, Sisli Etfal Training and Research Hospital, Istanbul, Turkey.OBJECTIVE: To evaluate the effect of daily oral and transdermal hormone therapy alone or in combination with alendronate on bone mineral density in postmenopausal women. DESIGN: Comparative prospective clinical study. SETTING: Outpatient clinic of a training and research hospital. PATIENT(S): One hundred seventy-three consecutive postmenopausal women with no previous hormone therapy and a bone mineral density T score <-1 SD were randomly enrolled. INTERVENTION(S): Oral conjugated estrogen, alone or with alendronate, or transdermal estrogen, alone or with alendronate, given for 1 year. All patients also received medroxyprogesterone acetate and calcium. MAIN OUTCOME MEASURE(S): Bone density measurement at L2 to 4 region by dual-energy X-ray absorptiometry. RESULTS: At the end of 1 year, significant increase in bone density measurements were seen in all groups. Oral conjugated estrogen and transdermal estrogen have the same effect on bone mineral density loss. Hormone therapy alone stabilized the bone mineral density loss. Hormone therapy together with alendronate resulted in better values in all groups. CONCLUSION: Hormone therapy is adequate in osteopenic women. However, hormone therapy plus alendronate is advantageous in women with considerable bone mineral density loss.
1: Am J Med. 2003 Aug 15;115(3):209-16. :
Early discontinuation of treatment for osteoporosis.
Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, Pressman AR, Ettinger B.
Department of Medicine, Dartmouth Medical School, Hannover, New Hampshire 03756, USA.
Anna.Tosteson@Dartmouth.edu
PURPOSE: To identify factors associated with early treatment discontinuation of three agents commonly prescribed for women with low bone density. METHODS: A telephone survey was conducted in 2000 to 2001 in a random sample of women aged 45 years or older who had bone density T-scores -1.0 or lower and who had initiated treatment with hormone replacement therapy, raloxifene, oral endronate. Logistic regression was used to estimate adjusted odds ratios for early treatment discontinuation. RESULTS: Among 956 women who were interviewed an average of 7 months after treatment initiation, 334 were taking hormone therapy, and 88 (26%) had discontinued; 256 were taking raloxifene, and 48 (19%) had discontinued (P = 0.03 vs. hormone therapy); and 366 were taking alendronate, and 70(19%) had discontinued (P = 0.02 vs. hormone therapy).Women with bothersome side effects (somewhat bothered: odds ratio [OR] = 4.0; 95% confidence interval [CI]: 2.5 to 6.5; very or extremely bothered: OR = 25; 95% CI: 16 to 39) or who thought that their bone density test results did not show osteoporosis (OR = 1.6; 95% CI: 1.0 to 2.5) were more likely to discontinue therapy, as compared with women reporting regular exercise (OR = 0.7; 95% CI: 0.4 to 1.0) or a willingness to take prescribed medications (OR = 0.6; 95% CI: 0.4 to 0.9).After adjustment for side effects and patient characteristics, the odds of early treatment discontinuation did not differ significantly among treatments. CONCLUSION: Improved adherence to osteoporosis treatment requires that treatment side effects be minimized and women be educated regarding their bone density test results.
1: Arthritis Rheum. 2003 Aug;48(8):2321-3. :
Comment in:
Arthritis Rheum. 2003 Aug;48(8):2097-9.
Bisphosphonate resistance in Paget's disease of bone.
Joshua F, Epstein M, Major G.
Royal Newcastle Hospital, Pacific Street, Newcastle, New South Wales 2300, Australia.
OBJECTIVE: To determine whether resistance to one bisphosphonate predicts resistance to another bisphosphonate. METHODS: One hundred patients with Paget's disease were treated with intravenous (IV) pamidronate. The initial dose was 120 mg, followed by further doses of 240 mg, until either biochemical remission was achieved or a total dose of 1 gm was given. Biochemical remission was defined as an alkaline phosphatase level within the reference range. Patients whose disease failed to respond to pamidronate were then treated with alendronate for 6 months. Patients whose disease failed to respond to alendronate were given either tiludronate for 3 months, or clodronate for 6 months. RESULTS: Sixteen of the 100 patients treated with pamidronate failed to achieve a biochemical response despite a cumulative dose of 1 gm. Of the 16 nonresponders, 1 died of an unrelated cause, and the remaining 15 patients were treated with alendronate. In 2 of these patients, the treatment was changed to another bisphosphonate because of gastrointestinal intolerance to alendronate. Of the remaining 13 patients, 9 (69%) achieved full biochemical remission. In 4 other patients, both pamidronate and alendronate therapy were unsuccessful (1 patient responded to tiludronate, tiludronate therapy was unsuccessful in 1, clodronate was unsuccessful in 1, and 1 patient elected to receive no further treatment). Of the 2 patients who could not receive alendronate because of gastrointestinal intolerance, 1 achieved normalization with tiludronate, and a repeat course of pamidronate was unsuccessful in the other. In total, 73% of patients in whom initial treatment with IV pamidronate was unsuccessful responded to a change in bisphosphonate treatment. CONCLUSION: Failure to achieve biochemical normalization is likely to be specific to the individual drug rather than indicative of bisphosphonate class resistance
1: Curr Opin Rheumatol. 2003 Jul;15(4):458-63. :
Bisphosphonates: new indications and methods of administration.
Reid IR.
Department of Medicine, University of Auckland, New Zealand.
i.reid@auckland.ac.nz
In the course of 2002, several new studies were published confirming the efficacy of bisphosphonate drugs in fracture prevention in patients with osteoporosis. Further evidence was provided of their long duration of action, making intermittent administration possible. The potent bisphosphonate zoledronate can be given at intervals of as long as 1 year and produces changes in bone density and in markers of bone turnover comparable with those seen with conventional daily oral dosing with alendronate or risedronate. If such regimens are proven to prevent fractures, their convenience is likely to result in their widespread adoption and potentially an increase in compliance with these medications. Further evidence has been presented documenting the value of bisphosphonates in preventing the skeletal complications of malignancy, and possibly in reducing mortality in patients with breast cancer. The role of bisphosphonates in osteogenesis imperfecta was further confirmed, and novel roles in ankylosing spondylitis, myelofibrosis, and hypertrophic pulmonary osteoarthropathy were suggested.
1: Keio J Med. 2003 Jun;52(2):113-9. :
Early response to alendronate after treatment with etidronate in postmenopausal women with osteoporosis.
Iwamoto J, Takeda T, Ichimura S, Uzawa M.
Department of Sports Medicine, Keio University School of Medicine, Tokyo, Japan.
jiwamoto@sc.itc.keio.ac.jp
The purpose of the present study was to examine the early response of lumbar bone mineral density (BMD), bone resorption, and back pain to alendronate after treatment with cyclical etidronate in postmenopausal women with osteoporosis. Forty postmenopausal women with osteoporosis, 60-83 years of age, without any vertebral fractures in the lumbar spine, were randomly divided into two groups with 20 patients in each group: 18 months of cyclical etidronate (200 mg daily for 2 weeks every 3 months) group and 12 months of cyclical etidronate followed by 6 months of alendronate (5 mg daily) group. BMD of the lumbar spine (L1-L4) measured by DXA, urinary cross-linked N-terminal telopeptides of type I collagen (NTX) level measured by enzyme-linked immunosorbent assay, and back pain evaluated by face scale score were assessed at baseline and every 6 months. There were no significant differences in baseline characteristics including age, body mass index, years since menopause, lumbar BMD, urinary NTX level, and face scale score between the two groups. Cyclical etidronate significantly reduced urinary NTx level and face scale score over 12 months, but did not significantly increase lumbar BMD. After 12 months of treatment, the switch to alendronate significantly reduced urinary NTX level and face scale score, and significantly increased lumbar BMD, while continued cyclical etidronate did not significantly alter these parameters. These results suggest that switching to alendronate after treatment with cyclical etidronate produces a greater response of lumbar BMD, bone resorption, and back pain than continued cyclical etidronate in postmenopausal women with osteoporosis
Drugs Today (Barc). 2003 May;39(5):339-46. :
Once weekly alendronate.
Sambrook P.
Professor of Rheumatology, University of Sydney, Sydney, Australia.
sambrook@med.usyd.edu.auAlendronate, a bisphosphonate that potently inhibits bone resorption, has been shown in long-term clinical trials to be an effective treatment for osteoporosis, increasing bone mineral density and substantially reducing the incidence of both vertebral and nonvertebral fractures, including hip fractures, mostly using a daily dosage regimen. Although daily administration has generally been well tolerated in these trials, some patients develop upper gastrointestinal symptoms. Current safety and efficacy data suggest that once-weekly dosing of alendronate appears to be as efficacious as daily administration in the treatment of osteoporosis, providing greater convenience to patients, improved compliance and a lower risk of upper gastrointestinal symptoms compared with daily administration. This review examines published data addressing the safety and efficacy of once-weekly alendronate administration. (c) 2003 Prous Science. All rights reserved.
1: J Obstet Gynaecol. 2003 May;23(3):278-81. :
Alendronate daily, weekly in conventional tablets and weekly in enteric tablets: preliminary study on the effects in bone turnover markers and incidence of side effects.
Blumel JE, Castelo-Branco C, de la Cuadra G, Maciver L, Moreno M, Haya J.
Climacteric Unit Barros Luco-Tradeau Hospital, Santiago, ChileBisphosphonates are now in the vanguard of osteoporosis treatment. Frequently, gastro-oesophageal symptoms are associated with these drugs. The objective of this study was to compare side effects and bone turnover markers in postmenopausal women who had received alendronate daily or weekly in tablets with or without enteric coating. We conducted a randomised, double-blind, 3-month trial. The trial involved 75 volunteers, aged 45-58 with moderate to severe osteopenia (T-score lower than -2 SD) assessed by quantitative ultrasound. Women were assigned randomly to receive: (a) alendronate 10mg/day: (b) alendronate 70 mg once a week: or (c) enteric alendronate 70 mg per week. We recorded side effects, C-telopeptide, osteocalcin and urine hydroxyproline at the start of the study and at 3 months. After 3 months, pyrosis (heartburn) was noted by seven women in group A (28%), three in group B (12%) and two in group C (8%); nausea: by one woman in group B; and headache by one patient in each group. C-telopeptide (A: 40.7%; B: 34.1% and C: 38.5%); hydroxyproline (A: 31.1%;B: 25.3% and C: 31.5%) and osteocalcin (A: 27.0%; B: 25.4% and C: 25.1%) decreased similarly in the three groups. Weekly intake of alendronate, whether conventional or enteric-coated; is associated with less heartburn and nausea. Enteric alendronate has a similar action to the conventional tablets on biochemical markers.
1: Am Fam Physician. 2003 Apr 1;67(7):1521-6. :
Osteoporosis in men.
Campion JM, Maricic MJ
.
Department of Medicine, University of Arizona Health Sciences Center, Tucson, Arizona 85724-5069, USA.Osteoporosis in men is now recognized as an increasingly important public health issue. About 30 percent of hip fractures occur in men, and one in eight men older than 50 years will have an osteoporotic fracture. Because of their greater peak bone mass, men usually present with hip, vertebral body, or distal wrist fractures 10 years later than women. Hip fractures in men, however, result in a 31 percent mortality rate at one year after fracture versus a rate of 17 percent in women. Major risk factors for osteoporosis in men are glucocorticoid use for longer than six months, osteopenia seen on plain radiographs, a history of nontraumatic fracture, hypogonadism, and advancing age. Bisphosphonates and teriparatide (recombinant parathyhroid hormone) have recently been approved for use in men and should be considered along with supplemental calcium and vitamin D. Increased awareness by physicians of risk factors for male osteoporosis--and early diagnosis and treatment--are needed to decrease the morbidity and mortality resulting from osteoporotic fractures
