• Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. (nih.gov)
  • The Fracture Intervention Trial aimed to investigate the effect of alendronate on the risk of morphometric as well as clinically evident fractures in postmenopausal women with low bone mass. (nih.gov)
  • FIT is a randomized, double-masked, placebo-controlled trial that was designed to determine the effect of alendronate on fracture incidence, and the current study was conducted as a secondary analysis of FIT data. (umn.edu)
  • The effect of alendronate on fracture-related healthcare utilization and costs: the fracture intervention trial [J]. Osteoporos Int, 2001, 12(8): 654-660. (cthhmu.com)
  • Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the Fracture Intervention Trial [J]. JAMA, 1999, 280(24): 2077-2082. (cthhmu.com)
  • Effect of alendronate on vertebral fracture risk in women with bone mineral density T scores of -1.6 to -2.5 at the femoral neck: The Fracture Intervention Trial [J]. Mayo Clin Proc, 2005, 80(3): 343-349. (cthhmu.com)
  • Conclusions: The results in this study indicate that treating osteoporotic men with alendronate was projected to be cost-effective, under the assumption of the same fracture-risk-reducing effect of alendronate for men as for women. (sogacot.org)
  • Combined abaloparatide and alendronate therapy reduced significantly the incidence of vertebral and nonvertebral fractures. (wikipedia.org)
  • Two systematic reviews involving postmenopausal women found that alendronate reduced vertebral and nonvertebral fractures compared with placebo after one to four years. (aafp.org)
  • One randomized controlled trial (RCT) involving women with prior vertebral fractures found that parathyroid hormone reduced the proportion of women with vertebral and nonvertebral fractures compared with placebo. (aafp.org)
  • One large RCT involving postmenopausal women with osteoporosis found that raloxifene reduced vertebral fractures compared with placebo, but no significant difference was found in nonvertebral fractures. (aafp.org)
  • One systematic review involving postmenopausal women found that etidronate reduced vertebral fractures compared with control (placebo, calcium, or calcium plus vitamin D) over two years but found no significant difference in nonvertebral fractures. (aafp.org)
  • Calcium Plus Vitamin D . One large RCT involving women 69 to 106 years of age living in nursing homes found that calcium plus vitamin D 3 reduced hip fractures and all nonvertebral fractures after 18 months to three years compared with placebo. (aafp.org)
  • One smaller RCT involving women and men 65 years or older found that calcium plus vitamin D 3 reduced nonvertebral fractures after three years compared with placebo but found no significant difference in hip fractures. (aafp.org)
  • One systematic review involving postmenopausal women found that calcitonin reduced vertebral fractures compared with placebo one to five years after treatment but found no significant difference between calcitonin and placebo in nonvertebral fractures. (aafp.org)
  • One systematic review involving postmenopausal women found no significant difference between calcium supplementation and placebo in vertebral or nonvertebral fractures after one and one half to four years. (aafp.org)
  • One large RCT involving postmenopausal women and two large RCTs involving postmenopausal women and older men provided no evidence of a difference between vitamin D 3 and placebo in hip, vertebral, and nonvertebral fractures after two to five years. (aafp.org)
  • An open-label randomized controlled trial was conducted to clarify the effect of eldecalcitol (ED) on body balance and muscle power in postmenopausal osteoporotic women treated with bisphosphonates. (scienceopen.com)
  • The present study showed that ED improved the chair-rising time in terms of muscle power in postmenopausal osteoporotic women treated with bisphosphonates. (scienceopen.com)
  • BACKGROUND Bisphosphonates inhibit bone resorption in patients with postmenopausal osteoporosis and reduce osteoporotic fracture incidence. (bvsalud.org)
  • Bisphosphonates have been shown to reduce the risk of osteoporotic fracture in numerous large clinical trials, particularly alendronate sodium have been extensively and successfully used for the treatment of osteoporosis. (cthhmu.com)
  • Efficacy of bisphosphonates in reducing fracture risk in postmenopausal osteoporosis [J]. Am J Med, 2009, 122(2 Suppl): S14-S21. (cthhmu.com)
  •  Fosamax was the first of a class of drugs called bisphosphonates which gave women an alternative to traditional treatments for osteoporosis (estrogen (female sex hormone) and calcitonin). (pharmawatchdog.com)
  • Bisphosphonates include Fosamax (alendronate), Zometa (zoledronic acid) and Boniva (ibandronate) used to treat osteoporosis. (tbrnewsmedia.com)
  • In a meta-analysis involving two randomized controlled trials, results showed there was no benefit from the use of bisphosphonates in reducing breast cancer risk (5). (tbrnewsmedia.com)
  • In a third study, a meta-analysis (group of 36 post-hoc analyses - after trials were previously concluded) using bisphosphonates, results showed that zoledronic acid significantly reduced mortality risk, by as much as 17 percent, in those patients with early breast cancer (7). (tbrnewsmedia.com)
  • THOUSAND OAKS, Calif. , April 15, 2019 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that EVENITY™ (romosozumab-aqqg) is now available for shipment to wholesalers in the U.S. EVENITY was approved by the U.S. Food and Drug Administration ( FDA ) on April 9, 2019 , for the treatment of osteoporosis in postmenopausal women at high risk for fracture. (amgen.com)
  • The approval of EVENITY in the U.S. helps address an unmet need by providing another option for postmenopausal women at high risk for fracture who need to build bone rapidly within 12 months and to reduce the risk of a first or subsequent fracture. (amgen.com)
  • Abaloparatide is indicated to treat postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. (wikipedia.org)
  • This research is inline with a growing need to treat women with osteoporosis and a high risk for fracture or post fracture more effectively and safely. (speakingofwomenshealth.com)
  • A total of 106 postmenopausal women with osteoporosis (mean age 70.8 years) were randomly divided into two groups (n=53 in each group): a bisphosphonate group (control group) and a bisphosphonate plus ED group (ED group). (scienceopen.com)
  • CONCLUSIONS This report raises awareness of both MRONJ and AFF as possible adverse effects of short-term bisphosphonate therapy for postmenopausal osteoporosis, and highlights the importance of dental and orthopedic follow-ups. (bvsalud.org)
  • The Fracture Intervention Trial (FIT) showed that the bisphosphonate alendronate reduces the risk of fractures and increases bone mineral density (BMD) in osteoporotic women. (sogacot.org)
  • looked at 3D modelling from hip DXA scans in postmenopausal women with osteoporosis who received oral bisphosphonate therapy for ≥3 years and ALN for ≥1 year prior to screening, and were randomized to ROMO or a comparator (STRUCTURE: teriparatide [TPTD]) for 12 months. (ucb.com)
  • The disparity in the above two bisphosphonate studies has to do with trial type. (tbrnewsmedia.com)
  • VANCOUVER, Canada - With treatment with a bisphosphonate following sequential use of teriparatide (Forteo) and denosumab (Prolia) for premenopausal women with idiopathic osteoporosis, bone mineral density (BMD) was maintained over the first year following denosumab cessation, according to results from a small, nonrandomized extension of a phase 2 study. (medscape.com)
  • The bisphosphonate phase of the extension study included 24 women (mean age, 43 years). (medscape.com)
  • In the phase III (2011-2014) Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial, an 18-months randomized, multicenter, double-blinded, placebo-controlled study evaluated the long-term efficacy of abaloparatide compared to placebo and teriparatide in 2,463 postmenopausal women (± 69 years old). (wikipedia.org)
  • Efficacy and Safety of Romosozumab Among Postmenopausal Women With Osteoporosis and Mild-to-Moderate Chronic Kidney Disease. (nih.gov)
  • The women who received romosozumab followed by alendronate were observed to have a 48% lower rate of new vertebral fractures when compared with those who only received alendronate. (mcgill.ca)
  • During the first year, serious cardiovascular events were observed more frequently in the romosozumab-alendronate group (50 of 2040 patients, or 2.5%, as compared with 38 of 2014, or 1.9%, in the alendronate only group). (mcgill.ca)
  • Evenity (romosozumab) is indicated for the treatment of osteoporosis in post-menopausal women at high risk of breaking a bone. (everydayhealth.com)
  • In the clinical trials of romosozumab, people taking the drug reduced their risk for fracture by more than 70 percent and had increases in bone density in their spines at around 15 percent - a very significant jump. (everydayhealth.com)
  • Post-hoc analyses of the FRAME, ARCH and the STRUCTURE phase 3 trials using 3D modelling techniques showed significant cortical and trabecular bone improvements during the first year in romosozumab-treated patients. (ucb.com)
  • So we are proud to communicate additional data supporting romosozumab as a bone forming option for postmenopausal women with severe osteoporosis at high risk of fracture," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions & Head of US, UCB. (ucb.com)
  • Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis [J]. N Engl J Med, 2007, 356(18): 1809-1822. (cthhmu.com)
  • Effect of once-yearly zoledronic acid on the spine and hip as measured by quantitative computed tomography: results of the HORIZON Pivotal Fracture Trial [J]. Osteoporos Int, 2010, 21(7): 1277-1285. (cthhmu.com)
  • The FIT study involved alendronate and the HORIZON-PFT study involved zoledronic acid, with these drugs compared to placebo. (tbrnewsmedia.com)
  • Weekly doses of alendronate (ALN) better suppressed C-terminal telopeptide (CTX) than did zoledronic acid (ZOL) and led to better maintenance of BMD than did a single dose of ZOL. (medscape.com)
  • FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. (merck.com)
  • Prevention of osteoporosis in postmenopausal women: 5 mg daily or 35 mg once weekly. (nih.gov)
  • One large RCT, which focused on estrogen plus progestin versus placebo for primary prevention of coronary heart disease in healthy postmenopausal women, was stopped because hormonal treatment increased risks of invasive breast cancer, coronary events, stroke, and pulmonary embolism. (aafp.org)
  • This was a trial for secondary prevention, where patients had a personal history of cancer. (tbrnewsmedia.com)
  • With women living longer into our 8th and 9th decades of life, the goal of osteoporosis treatment and fracture prevention is to live more pain free and independent lives. (speakingofwomenshealth.com)
  • WHITEHOUSE STATION, N.J.-(BUSINESS WIRE)-Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. (merck.com)
  • At trial, Merck presented evidence that it acted responsibly in researching and developing FOSAMAX and in monitoring the medicine since it has been on the market. (merck.com)
  • The company's clinical trials, conducted both before and following approval, have involved more than 28,000 patients, including more than 17,000 treated with FOSAMAX. (merck.com)
  • This is the third FOSAMAX case to go to trial. (merck.com)
  • The second trial over the drug Fosamax resulted in a verdict of $8 million dollars for Shirely Boles. (pharmawatchdog.com)
  • Merck's Fosamax (drug: Alendronate) is used to treat two bone disorders, osteoporosis in postmenopausal women and Paget’s disease. (pharmawatchdog.com)
  • Merck states that they are responsible for the patient safety and hence enough patient safety data was collected from clinical trials and post marketing trials of Fosamax. (pharmawatchdog.com)
  • Another small RCT involving post-menopausal women found no significant difference between calcium plus vitamin D 3 and placebo in hip fractures after two years. (aafp.org)
  • However, another systematic review and two subsequent RCTs involving post-menopausal women found no significant difference in vertebral fractures. (aafp.org)
  • Affecting both male and females, it is more common in women, affecting post-menopausal women at a rate of 1 in 4 [ 2 ]. (biomedcentral.com)
  • Their findings indicate that, in general, a small, statistically significant protective effect of exercise on bone density was noted in post-menopausal women as compared with control groups. (biomedcentral.com)
  • Estrogen has largely been abandoned for post-menopausal women, but the use of very low dose estrogen (one half of a 0.625 mg tablet per day or very low dose patch) when combined with two weeks off estrogen every three-six months has been found helpful in preventing estrogen deficiency symptoms and is also quite good at preventing osteoporosis. (modern-psychiatry.com)
  • A regimen of a novel bone anabolic medication (which builds bone mass) followed by an antiresorptive agent (which maintains bone mass) has been shown to significantly reduce the risk of fracture among post-menopausal women with severe osteoporosis, according to results of a clinical trial published in The New England Journal of Medicine. (mcgill.ca)
  • Osteoporosis is a serious condition affecting both women and men, with post-menopausal women being particularly susceptible. (mcgill.ca)
  • Evenity offers a new osteoporosis treatment for post-menopausal women at high risk of bone fracture. (everydayhealth.com)
  • The safety and efficacy of Evenity was shown in two clinical trials involving a total of more than 11,000 women with post-menopausal osteoporosis. (everydayhealth.com)
  • Jeal W, Barradell LB, McTavish D. Alendronate: a review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis. (jamanetwork.com)
  • In clinical studies there was no age-related difference in the efficacy or safety profiles of alendronate. (pillintrip.com)
  • Alendronate sodium is not recommended for use in children under the age of 18 years due to insufficient data on safety and efficacy in conditions associated with paediatric osteoporosis. (pillintrip.com)
  • Other agents, such as denosumab and testosterone in men, have not been tested in eating-disordered populations and should only be trialed on an empiric basis if there is a high clinical concern for fractures or worsening bone mineral density. (biomedcentral.com)
  • There was a 2% decline in BMD in the forearm (distal radius [DR]). A group of 32 of the women participated in an extension study and took denosumab for 12 months. (medscape.com)
  • These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. (nih.gov)
  • See full prescribing information for ALENDRONATE SODIUM TABLETS. (nih.gov)
  • o Not lie down for at least 30 minutes after taking alendronate sodium tablets and until after food. (nih.gov)
  • Alendronate sodium tablets, USP are indicated for the treatment of osteoporosis in postmenopausal women. (nih.gov)
  • In postmenopausal women, alendronate sodium tablets, USP increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). (nih.gov)
  • Women who received daily injections of abaloparatide experienced substantial reduction in the incidence of fractures compared to placebo. (wikipedia.org)
  • or 10 mg daily in postmenopausal women not receiving estrogen. (nih.gov)
  • OBJECTIVE: Secoisolariciresinol diglucoside (SDG) is a phytoestrogen that has been reported to improve postmenopausal osteoporosis (PMOP) caused by estrogen deficiency. (bvsalud.org)
  • The most common side effects reported by more than 2% of clinical trials subjects are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain and vertigo. (wikipedia.org)
  • A clinical practice guideline from the American College of Physicians on treatment to prevent fractures in men and women with low bone density or osteoporosis includes six recommendations: two strong recommendations, based on high- or moderate-quality evidence, and four weak ones, based on low-quality evidence. (medscape.com)
  • What are the effects of treatments to prevent fractures in postmenopausal women? (aafp.org)
  • This was followed by alendronate, an antiresorptive agent commonly used as first-line therapy for osteoporosis, that maintains existing levels of bone mass. (mcgill.ca)
  • One systematic review involving postmenopausal women found that hormone therapy reduced vertebral fractures compared with control. (aafp.org)
  • Three weeks later, she was discharged from the hospital, instructed to discontinue the use of alendronate, and referred for 30 sessions of hyperbaric oxygen therapy. (bvsalud.org)
  • 3 Significant reductions in fracture risk were seen in less than 2 years in therapy trials. (racgp.org.au)
  • Currently, weight restoration, resumption of a regular menstrual period in women and ensuring adequate vitamin D and calcium levels are the mainstays of therapy. (biomedcentral.com)
  • A guidance on the assessment and treatment of postmenopausal women at risk from fractures due to osteoporosis was recently published in Osteoporosis International as a joint effort of the International Osteoporosis Foundation and European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (Kanis et al. (edu.au)
  • In women over 45 years of age, fractures due to osteoporosis result in more days spent in hospital than many other diseases, including diabetes, heart attacks, stroke and breast cancer. (osteoporosis.org.za)
  • This benefit was seen in postmenopausal women but not in premenopausal women. (tbrnewsmedia.com)
  • Any patient with lower than average BMD should weight restore and in premenopausal females, spontaneous menses should resume. (biomedcentral.com)
  • Although there is evidence to support this treatment sequence for postmenopausal women, there was no evidence regarding premenopausal women with idiopathic osteoporosis, said Adi Cohen, MD, who presented the results of the study at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting. (medscape.com)
  • It is too early to call the results practice changing, said Cohen, professor of medicine and endocrinology at Columbia University Irving Medical Center (CUIMC), but she noted, "It's important just to provide information about how sequences of osteoporosis medications might be used in a rare but certainly understudied group of premenopausal women with osteoporosis who need treatment, and these data hopefully will help make some treatment decisions. (medscape.com)
  • In the early 2000s, researchers initially believed that premenopausal women with low BMD had experienced some kind of temporary event and that they would likely improve on their own over time. (medscape.com)
  • Women aged 55-81 with low femoral-neck BMD were enrolled in two study groups based on presence or absence of an existing vertebral fracture. (nih.gov)
  • To address this issue, we prospectively assessed post-fracture disability at multiple skeletal sites in a population of 909 older (aged 55-81 years), community-dwelling women with low femoral neck bone mineral density who had experienced a fracture while enrolled in the Fracture Intervention Trial (FIT). (umn.edu)
  • BMD values at the spine and femoral neck were compared in 34 women with vertebral fracture and 34 controls. (who.int)
  • T-score was not sensitive enough to identify low BMD in the spine, whereas the femoral neck T-score could recognize women at high risk of fracture with higher accuracy. (who.int)
  • Women with T-scores at the hip, femoral neck or spine which are lower than -2.5 have osteoporosis or bones weak enough to fracture with minimal trauma such as lifting or twisting in some cases. (speakingofwomenshealth.com)
  • In a randomized controlled trial in postmenopausal women, there was a higher rate of major adverse cardiac events (MACE), a composite endpoint of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, in patients treated with EVENITY ® compared to those treated with alendronate. (evenityproliahcp.com)
  • it's really powerful," says Felicia Cosman, MD , a professor of clinical medicine at Columbia University College of Physicians and Surgeons in New York City and a principal investigator in the FRAME trial, one of the two Evenity trials submitted for FDA approval of the drug. (everydayhealth.com)
  • One systematic review found limited evidence from two small RCTs involving postmenopausal women that calcitriol reduced vertebral fractures after three years compared with placebo. (aafp.org)
  • Many randomized controlled trials (RCTs) have investigated drug treatment for women at high risk of fracture, with a reduction in fracture risk as their end point. (elsevierpure.com)
  • A 24-week randomized trial was conducted in postmenopausal women with osteoporosis (n=222) assessing bone mass density (BMD) changes as the primary endpoint. (wikipedia.org)
  • The CTFPHC concludes that there is fair evidence to screen postmenopausal women to prevent fragility fractures. (canadiantaskforce.ca)
  • Over a two-year period, 4,093 women with osteoporosis and a fragility fracture were randomly assigned to one of two groups. (mcgill.ca)
  • Age, family history of OP, female gender, age at menopause and prior fragility fracture are all potent risk factors for future fragility fracture, but these factors can't be changed. (racgp.org.au)
  • Although these studies observed numerous adverse effects, another double-blinded, placebo-controlled trial evaluating the impact of 4 weeks of ibutamoren administration in 32 healthy elderly patients observed no AEs. (medicalopedia.org)
  • Alendronate sodium is not indicated for use in pediatric patients. (nih.gov)
  • Trials have shown that starting Parkinson's disease patients on selegiline can extend the time period before they need l-dopa by about nine months. (digitalnaturopath.com)
  • The single randomized, double-blind, placebo-controlled trial in which ibutamoren was evaluated with recovery from hip fracture was halted early due to concerns that it might increase the risk of congestive heart failure in elderly patients. (medicalopedia.org)
  • Only 6 of 36 in the ibutamoren-alendronate group, 3 of 36 patients in the placebo group, and 11 of 111 in the ibutamoren-alendronate group dropped out of the study due to clinical AEs. (medicalopedia.org)
  • Keeping patients at a constant bone mass isn't adequate when they are already suffering from osteoporosis and their bones aren't strong enough to resist fracture," said Dr. Andrew Karaplis, a Professor of Medicine at McGill University who researches metabolic bone disease at the Lady Davis Institute and treats osteoporotic patients at the Jewish General Hospital, one of the centres participating in this phase 3 clinical trial. (mcgill.ca)
  • Alendronate is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience. (pillintrip.com)
  • More of my patients are aware that heart disease is the number 1 killer of women. (speakingofwomenshealth.com)
  • For women aged 65 and older who have osteopenia and are at high fracture risk, decisions to treat should take into account patient preference, fracture-risk profile, benefits, harms, and price of medications. (medscape.com)
  • The aim this study was to determine which BMD parameter can best predict women at high risk of fracture. (who.int)
  • There has also been progress in identifying women at the highest risk of fractures. (elsevierpure.com)
  • An estimated 10 million Americans, 90% women, suffer from osteoporosis with an elevated risk of bone fractures with another 34 million having less severe bone thinning called osteopenia. (modern-psychiatry.com)
  • Sadly, only a very few American women at risk for osteoporosis and fractures are being recommended preventive treatment. (modern-psychiatry.com)
  • Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial. (cthhmu.com)
  • The risk for mortality following hip fracture is higher for men compared to women. (sogacot.org)
  • Objective: To investigate the cost effectiveness of alendronate for male osteoporosis in Sweden by assuming the same relative risk reduction of fractures in men as for women, based on the FIT trial. (sogacot.org)
  • Several risk factors increase the chance of developing osteoporosis: family history, gender (women are 6 to 8 times more likely than men), being postmenopausal, advanced age, race (Caucasians are the most likely), low calcium intake, smoking, alcohol consumption, a sedentary lifestyle, 4 and soft drink consumption. (naturalmedicinejournal.com)
  • I'm very excited for a new treatment option for myself, as well as the thousands of other women who may benefit from a treatment that will build bone and slow bone loss. (amgen.com)