PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Risedronic Acid”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 19 recordsLinked to original sources
PubMed2006

Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international.

BACKGROUND: The objective of the study was to evaluate the effects of alendronic acid once weekly relative to risedronic acid once weekly on bone mineral density (BMD), markers of bone turnover and tolerability in the treatment of osteoporosis in postmenopausal women. METHODS: This was a randomised, double-masked, double-dummy multicentre international study (75 centres in 27 countries in Europe, the Americas and Asia-Pacific). A total of 1303 women were screened and 936 with low bone density (T-score < or = -2.0 at the spine, hip trochanter, total hip or femoral neck) were randomised; 91% (n = 854) completed the study. Patients were randomised to treatment with either active alendronic acid 70 mg weekly (Fosamax) and placebo identical to risedronic acid weekly or active risedronic acid 35 mg weekly (Actonel) and placebo identical to alendronic acid weekly for 12 months. The primary efficacy endpoint was the percentage change from baseline in hip trochanter BMD at 12 months. Secondary endpoints included the percentage change from baseline in lumbar spine, total hip and femoral neck BMD; biochemical markers of bone turnover (including serum bone-specific alkaline phosphatase [BSAP] and urinary type I collagen N-telopeptides [NTx]); and safety and tolerability as assessed by reporting of adverse experiences. RESULTS: Alendronic acid produced greater increases in BMD than did risedronic acid at 12 months at all sites measured. Mean percentage increases from baseline in hip trochanter BMD at month 12 were 3.56% and 2.71% in the alendronic acid and risedronic acid groups, respectively (treatment difference [95% CI]: 0.83% [0.22, 1.45; p = 0.008]). Mean percentage increases from baseline were greater with alendronic acid than risedronic acid at the lumbar spine, total hip and femoral neck BMD at month 12 (p = 0.002, p < 0.001, p = 0.039, respectively). Increases in BMD with alendronic acid compared with risedronic acid were also significantly greater at 6 months at the trochanter and total hip. There was a greater reduction in bone turnover with alendronic acid compared with risedronic acid: NTx decreased 58% with alendronic acid compared with 47% with risedronic acid at 12 months (p < 0.001); and BSAP decreased 45% with alendronic acid compared with 34% with risedronic acid at 12 months (p < 0.001). Overall tolerability and upper gastrointestinal tolerability were similar for both agents. CONCLUSIONS: Alendronic acid once weekly produced greater BMD increases at both hip and spine sites and greater reductions in bone turnover relative to risedronic acid once weekly. Both agents were well tolerated with no significant difference in upper gastrointestinal adverse experiences. Clinicians should consider these results when making treatment decisions for postmenopausal women with osteoporosis.

Aged↗
PubMed2005

Pharmacological management of severe postmenopausal osteoporosis.

The most devastating consequence of osteoporosis is bone fracture, particularly at the vertebral or femoral level. As defined by the WHO, patients with osteoporosis who have had one or more fragility fractures have severe osteoporosis. Those who sustain a vertebral fracture represent a particularly vulnerable group whose risk of another vertebral fracture within the following year is increased by a factor of 3-5. In addition, the presence of a vertebral fracture is associated with an increased risk of hip fracture. In light of these data, treatment of established osteoporosis is extremely important to prevent other fragility fractures. This review examines the therapies approved by the US FDA for the treatment of osteoporosis that have been shown to reduce the incidence of new fractures in patients with established osteoporosis. We evaluated the mechanisms of action, available formulations, efficacy in preventing fractures and increasing bone mineral density (BMD), duration of treatment, adverse effects and contraindications to use of alendronic acid (alendronate), risedronic acid (risedronate), calcitonin, raloxifene and teriparatide. All these drugs are able to prevent new vertebral fractures in patients with established osteoporosis. Only alendronic acid and risedronic acid have also been shown to reduce the risk of fracture at the femoral level, but they are contraindicated in patients with upper gastrointestinal diseases. Calcitonin is a good option in subjects with back pain because of its analgesic effect. Raloxifene is useful when patients have high plasma lipid levels or a family history of breast cancer. Teriparatide is indicated in subjects with very low BMD and multiple vertebral fractures. Patient characteristics should determine selection of therapy but the decision is always difficult and fraught with uncertainty.

Aged↗
PubMed2000

Preventing fractures in postmenopausal women with osteoporosis. A review of recent controlled trials of antiresorptive agents.

The evidence from randomised, controlled trials of the ability of antiresorptive treatments to reduce the risk of fractures in postmenopausal women with osteoporosis is reviewed and summarised. The aminobisphosphonates, alendronic acid and risedronic acid, and the selective estrogen receptor modulator raloxifene have all been shown to reduce the incidence of radiographic vertebral fractures. Only alendronic acid and risedronic acid have been shown to reduce the incidence of non-spine fractures in women with postmenopausal osteoporosis. There is evidence of antifracture efficacy for calcium plus vitamin D, primarily in a nursing home setting or in people with low intakes of these nutrients. Furthermore, since both the placebo and active treatment groups received calcium and vitamin D in most controlled trials of antiresorptive agents, it appears that the other agents provide benefits beyond those of calcium and vitamin D alone. There is insufficient published evidence from randomised controlled trials to convincingly support the antifracture efficacy of other agents, including calcitonin, estrogen and etidronic acid, at this time. Data from observational studies suggest, however, that estrogen and etidronic acid may have antifracture efficacy in this population.

Calcitonin↗
PubMed2006

Long-term safety of bisphosphonate therapy for osteoporosis: a review of the evidence.

This article reviews the long-term safety profile of bisphosphonates for the treatment and prevention of osteoporosis in postmenopausal women. Bisphosphonates inhibit osteoclastic resorption and reduce the rate of bone turnover, thereby reducing fracture risk. Placebo-controlled trials of oral amino-bisphosphonates of up to 4 years' duration and continuous treatment for up to 10 years in extensions of these trials (without continuous placebo comparison groups) have reported that bone quality remains normal, and suggest that the early reductions in fracture risk may be sustained for as long as treatment continues. Studies in animals using high doses of bisphosphonates have also reported normal quality bone with increased strength. The adverse experience profile (including upper gastrointestinal tolerability) of the oral bisphosphonates alendronic acid and risedronic acid has been similar to placebo in randomised trials with thousands of participants, whereas the incidence of flu-like symptoms was increased with the high doses used in oral monthly and intravenous ibandronic acid. Thus, the existing data are reassuring for long-term continued daily (or its weekly equivalent) administration of alendronic acid and risedronic acid, with no evidence of an adverse effect on bone health. For other dosing regimens, additional data are needed to evaluate their long-term safety.

Animals↗
PubMed2002

The underuse of therapy in the secondary prevention of hip fractures.

There is strong evidence to indicate that individuals who sustain a hip fracture are at a greater risk of developing another. The management of such patients should include efforts to prevent future fractures, including prescribing medications that have been shown to lower hip fracture risk. Such therapies that are currently available include calcium and vitamin D supplementation, alendronic acid and risedronic acid. In addition, there is epidemiological evidence to indicate that estrogen may also decrease the risk of hip fracture. Parathyroid hormone is another agent that has shown promise in this regard and is likely to be available for clinical use in the near future. However, the rates of utilisation of these therapies among patients with hip fractures are low. It is important to emphasise that secondary prevention of hip fractures should be an integral part of the management of individuals who sustain hip fractures.

Accidental Falls↗
PubMed2006

Importance of calcium co-medication in bisphosphonate therapy of osteoporosis: an approach to improving correct intake and drug adherence.

BACKGROUND AND OBJECTIVE: In all of the large, pivotal, multicentre trials of bisphosphonate therapy, patients have received added calcium in amounts ranging from 500 to 1000 mg/day above individual dietary intake. Accordingly, calcium supplements or calcium/vitamin D combinations are currently recommended as co-medication with anti-resorptive therapy in all recently published guidelines on the treatment of osteoporosis. However, the consistent use or effectiveness of calcium may be impaired by several factors in the individual patient, including low prescription rate or lack of advice to purchase calcium, reduced adherence because of the complexity of the regimen, and incorrect intake (e.g. taking calcium with bisphosphonates at the same time). Patients with osteoporosis who adhere to drug therapy experience a significantly lower fracture rate. Therefore, there is a need to improve correct intake of bisphosphonates together with calcium supplementation, which may enhance adherence. The dosage regimen could be simplified by providing the two compounds in an integrated pack. Such a pack, containing one tablet of risedronic acid and six calcium carbonate tablets (Actonel), Procter & Gamble Pharmaceuticals, Weiterstadt, Germany), has been developed to facilitate correct intake. In this study, the impact of this fixed-combination pack on patient understanding of dosing instructions and on preference was tested by comparing the fixed combination with separate risedronic acid and calcium packages. PATIENTS AND METHODS: A new blister strip was developed containing one tablet of risedronic acid 35mg and six tablets of calcium carbonate 1250mg (500mg elemental calcium), representing 1 week of therapy; the control was the same medications in separate packaging. The study was conducted in a cohort of 164 postmenopausal women (mean age 69 years). Half of the participants were bisphosphonate users (n = 83). The combined understanding of five instructions - risedronic acid intake in the morning, only with water, without food, without other medication, and separate from calcium - was tested in a crossover design. Participants were also asked to state their preference for the combination packaging versus separate packs. RESULTS: Understanding of the five instructions for the separate packaging was 70%. The combination pack significantly improved understanding of these instructions to 80% (p < 0.05). Eighty-three percent of participants preferred the combination pack over separate packs (p < 0.05). The most frequently given reasons for preferring the combination pack were prefer one pack over two packs, easy/convenient to use/practical/handy, easy to understand/less confusion, and easier to remember/less likely to forget. CONCLUSIONS: The availability of a fixed-combination pack of risedronic acid 35 mg/week and calcium tablets can increase the likelihood that postmenopausal osteoporotic patients will receive both a bisphosphonate and calcium, which in turn is likely to enhance the correct intake of combination therapy.

Aged↗
PubMed2005

Pharmacokinetics/pharmacodynamics of bisphosphonates: use for optimisation of intermittent therapy for osteoporosis.

Bisphosphonates suppress osteoclast-mediated bone resorption and are widely used in the management of osteoporosis. Daily oral administration of alendronic acid and risedronic acid have been shown to reduce the risk of vertebral and non-vertebral fractures. Once-weekly regimens with these bisphosphonates are pharmacologically equivalent to daily regimens. Regimens with treatment-free intervals longer than 1 week present an attractive therapeutic option as they may offer additional patient convenience and long-term adherence to treatment. However, until recently, such regimens, usually referred to as intermittent or cyclical, have not shown any convincing antifracture efficacy in clinical trials, probably because of the empirical manner in which the design of these regimens has been approached. Investigation of pharmacokinetics/pharmacodynamics of bisphosphonates may help in the design of effective intermittent dosage regimens. Bisphosphonates are poorly absorbed from the gastrointestinal tract and about 50% of the absorbed drug is taken up selectively by the skeleton, while the rest is excreted unaltered in urine. Bisphosphonates exert their action at the bone surface, where they are taken up by the osteoclasts during bone resorption. Therefore, when describing the pharmacokinetics of bisphosphonates in relation to the pharmacodynamics, the amount of bisphosphonate at the skeleton should be accounted for. Few of the reported clinical pharmacokinetic studies addressed this issue. This is partly due to the absence of study design elements to account for skeletal binding of the drugs. Pharmacokinetic studies have also been hampered by technical difficulties in determining the concentration of bisphosphonates in serum and urine. Moreover, most clinical pharmacokinetic (but also pharmacokinetic/pharmacodynamic) studies have primarily used noncompartmental analysis, leaving out the distinct advantages of modelling and simulation techniques. Clinically, the primary action of bisphosphonates can be assessed by the measurement of biochemical markers of bone resorption. Recent studies indicate that the pattern of these markers during bisphosphonate treatment may be predictive of antifracture efficacy; however, only limited data are available for the development of pharmacokinetic/pharmacodynamic models that are able to predict the response of these markers to different treatment regimens with bisphosphonates. Recently, pharmacokinetic/pharmacodynamic models for response to bisphosphonates have been described and, at present, some of them are being used in the design of bisphosphonate regimens with long drug-free intervals.

Animals↗
PubMed2002

Modern therapy for Paget's disease of bone: focus on bisphosphonates.

There has been a dramatic change in the therapeutic approach to patients with Paget's disease of bone over the last 40 years. In the 1960s, only symptomatic therapy could be given, with control of pain the main objective. Analgesics and nonsteroidal anti-inflammatory drugs were the most commonly used agents. From 1968 onwards, antiosteoclastic agents became available, including calcitonin, plicamycin (mithramycin) and etidronate (etidronic acid), a first-generation bisphosphonate. Limitations with these agents, including potentially deleterious effects on bone mineralization with etidronate (etidronic acid), has cleared the way for increasingly potent second- and third-generation bisphosphonates, including clodronate (clodronic acid), pamidronate (pamidronic acid), alendronate (alendronic acid) and risedronate (risedronic acid). Even more potent bisphosphonates will become available in the near future. With the newer bisphosphonates, there is some hope for long-term remission (if not definitive healing) of pagetic lesions, as well as prevention of long-term complications in both symptomatic and asymptomatic patients. Thus, indications for therapy have been extended to include younger patients to prevent bone deformity of the limbs and skull, leading to secondary osteoarthritis, facial deformities and potentially to sarcoma transformation; as well as to elderly patients to prevent bone fragility, leading to fracture, and pagetic vascular steal syndromes. The increased potency and longer duration of action of newer bisphosphonates more than compensates for their marginally increased cost compared with older bisphosphonates.

Animals↗
PubMed2002

Corticosteroid-induced osteoporosis: a guide to optimum management.

Corticosteroid-induced osteoporosis is the leading cause of secondary osteoporosis and a significant cause of morbidity in both men and women. Long-term use of even low-dose corticosteroids has been associated with increased risk of bone loss. Recent large randomized controlled trials have generated new knowledge on treatment strategies for patients with corticosteroid-induced osteoporosis. However, the majority of individuals receiving corticosteroids are not receiving prophylaxis for osteoporosis. Calcium and vitamin D should be recommended to patients initiating therapy with corticosteroids (and should be adequate for those receiving corticosteroids for less than 3 months). For those receiving corticosteroids for greater than 3 months, bisphosphonates are the therapy of choice, with both alendronate (alendronic acid) and risedronate (risedronic acid) approved by the US FDA for use in this indication. Calcitonin can be considered a second-line agent and should be reserved for patients who are intolerant of bisphosphonates or who are experiencing pain from a vertebral fracture. Hormone replacement therapy or testosterone therapy may be offered to those individuals on long-term corticosteroid treatment who are hypogonadal. Teriparatide (recombinant human parathyroid hormone 1-34) shows promise as a future anabolic agent for the prevention and treatment of patients with corticosteroid-induced osteoporosis.

Adrenal Cortex Hormones↗
PubMed2003

Prevention and treatment of postmenopausal osteoporosis.

Osteoporosis is a systemic disease characterized by low bone mass and microarchitectural deterioration of the skeleton leading to enhanced bone fragility and an increased risk of fracture. Prior to fracture, diagnosis is established by documenting low bone mass. In the first section of this article we review the clinical use of bone mass measurements and biochemical markers of bone remodeling in selecting patients most in need of preventive therapy at menopause. Women with high bone turnover lose bone at menopause more rapidly than those with normal bone turnover and are more likely to derive benefit from the several preventive therapies available. The second section addresses the available technologies used to diagnose osteoporosis and/or establish fragility fracture risk using noninvasive bone mass measurement and biochemical markers of bone remodeling separately or in combination. In the third section we review the several treatment options available for patients with osteoporosis, including alendronate (alendronic acid), risendronate (risedronic acid), calcitonin, teriparatide, and raloxifene, and the approaches to monitoring the therapeutic response. The final section deals with fall protection--an often forgotten aspect of management of the patient at risk for sustaining and osteoporotic fragility fracture.

Accidental Falls↗
PubMed2001

Ocular adverse effects of alendronic acid.

(1) The ocular adverse effects of pamidronic acid are rare but well documented. The main risk is anterior uveitis. (2) Similar disorders have been linked to alendronic acid and risedronic acid. The ocular manifestations occur rapidly after treatment introduction and resolve on treatment cessation. (3) The other diphosphonates seem to be exempt from this ocular risk.

Alendronate↗
PubMed2007

Long-term control of bone turnover in Paget's disease with zoledronic acid and risedronate.

UNLABELLED: A single 5-mg infusion of zoledronic acid restores biochemical markers of bone turnover into the reference range in the majority of patients with Paget's disease and maintains biochemical remission for at least 2 years. This effect is largely independent of pretreatment disease activity and prior bisphosphonate therapy. INTRODUCTION: Zoledronic acid (ZOL) is a potent bisphosphonate that produces a rapid and complete control of the increased bone turnover of Paget's disease. Long-term control of disease activity is an important aim of treatment in the hope that this will reduce the risk of complications such as deformity, fracture, and degenerative joint disease. MATERIALS AND METHODS: This study compares the ability of ZOL 5 mg given as a 15-minute intravenous infusion with risedronate (RIS) 30 mg daily by mouth for 60 days to maintain long-term control of bone turnover. No bisphosphonate was given during the extension study. All patients (n = 296) who achieved a therapeutic response, defined as normalization or a >75% reduction in the total alkaline phosphatase (total ALP) excess above the midpoint of the reference range, were eligible for inclusion. RESULTS: ZOL maintained the mean level of total ALP at the middle of the reference range, whereas those treated with risedronate showed a linear increase in total ALP from the 6-month post-treatment time-point. Both treatments resulted in a linear relationship between the 6-month nadir and 24-month total ALP. The relationship for RIS was shifted upward, showing that for a given level of post-treatment biochemical activity, bone turnover increased with time. This was in contrast to the ZOL-treated patients where total ALP generally remained unchanged over this 18-month extension period. A similar pattern of response was seen with the other bone turnover markers. CONCLUSIONS: ZOL maintains bone turnover within the reference range over 24 months from the initiation of treatment. A reduction in the incidence and severity of long-term complications may require persistent normalization of bone turnover over many years, and this now seems a realistic possibility with ZOL.

Administration, Oral↗
PubMed2005

Comparison of a single infusion of zoledronic acid with risedronate for Paget's disease.

BACKGROUND: The advent of bisphosphonates advanced therapy for Paget's disease, but more effective and convenient agents are needed to increase adherence. Zoledronic acid, a bisphosphonate administered as a single intravenous infusion, might meet these needs. METHODS: In two identical, randomized, double-blind, actively controlled trials of 6 months' duration, we compared one 15-minute infusion of 5 mg of zoledronic acid with 60 days of oral risedronate (30 mg per day). The primary efficacy end point was the rate of therapeutic response at six months, defined as a normalization of alkaline phosphatase levels or a reduction of at least 75 percent in the total alkaline phosphatase excess. The results of the studies were pooled. RESULTS: At six months, 96.0 percent of patients receiving zoledronic acid had a therapeutic response (169 of 176), as compared with 74.3 percent of patients receiving risedronate (127 of 171, P<0.001). Alkaline phosphatase levels normalized in 88.6 percent of patients in the zoledronic acid group and 57.9 percent of patients in the risedronate group (P<0.001). Zoledronic acid was associated with a shorter median time to a first therapeutic response (64 vs. 89 days, P<0.001). Higher response rates in the zoledronic acid group were consistent across all demographic, disease-severity, and treatment-history subgroups and with changes in other bone-turnover markers. The physical-component summary score of the Medical Outcomes Study 36-item Short-Form General Health Survey, a measure of the quality of life, increased significantly from baseline at both three and six months in the zoledronic acid group and differed significantly from those in the risedronate group at three months. Pain scores improved in both groups. During post-trial follow-up (median, 190 days), 21 of 82 patients in the risedronate group had a loss of therapeutic response, as compared with 1 of 113 patients in the zoledronic acid group (P<0.001). CONCLUSIONS: A single infusion of zoledronic acid produces more rapid, more complete, and more sustained responses in Paget's disease than does daily treatment with risedronate.

Administration, Oral↗
PubMed2003

Risedronate once a week.

Risedronate (risedronic acid), an orally administered pyridinyl bisphosphonate, inhibits osteoclast-mediated resorption of bone and modulates bone metabolism in women with postmenopausal osteoporosis. The long terminal exponential half-life of risedronate (480 hours) has led to the development of a 35mg tablet for once-a-week administration. The beneficial effects of risedronate 35mg once a week on total hip, femoral neck and trochanter bone mineral density (BMD) at 12 months were similar to those of risedronate 5mg once daily. Risedronate 35mg once a week was as effective as risedronate 5mg once daily in improving lumbar spine BMD in a randomized, double-blind, multicenter trial of 1456 women with postmenopausal osteoporosis. Mean percentage increases in BMD from baseline at 12 months were 3.94% and 4.25% in the 35mg and 50mg once-a-week dose groups, compared with 4% in the 5mg once-daily dose group. The differences between the once-a-week doses and the once-daily dose met the predetermined criterion for non-inferiority. An historical analysis suggested that risedronate 35mg once a week reduced the incidence of vertebral fracture significantly more than placebo. The tolerability profile (including the incidence of upper gastrointestinal adverse events) of risedronate 35mg once a week in women with postmenopausal osteoporosis, was similar to that of risedronate 5mg once daily.

Bone Density↗
PubMed2001

Risedronate: a clinical review.

BACKGROUND: Risedronate sodium has recently been approved for the prevention and treatment of postmenopausal and corticosteroid-induced osteoporosis. METHODS: Studies of risedronate were obtained from the MEDLINE database (1966 to the present) of references using risedronate, risedronic acid, osteoporosis, and human subject as keywords. Additional references were sought from the reference lists of the articles obtained. RESULTS: Nine randomized controlled trials and 7 other clinical trials were obtained. In postmenopausal women with normal bone density, risedronate increases lumbar spine bone density and preserves femoral neck density. In postmenopausal women with prior vertebral fracture, risedronate decreases new vertebral and nonvertebral fracture incidence. In patients who experienced breast cancer and who have chemotherapy-induced menopause, risedronate preserves bone. Risedronate prevents vertebral bone loss in patients beginning long-term corticosteroid therapy. Risedronate decreases pagetic bone pain and induces radiological improvement in pagetic lesions. Risedronate induces normalization of biochemical abnormalities and may be more effective than etidronate disodium for Paget disease. Only one study, a trial in patients with postmenopausal osteoporosis using a low dose (2.5 mg) of risedronate, did not have a positive result. Adverse effects in patients with postmenopausal osteoporosis, breast cancer, and Paget disease and in those taking corticosteroids are similar to those of patients taking placebo, and do not include notable upper gastrointestinal tract adverse event rates or serious adverse events. CONCLUSIONS: Risedronate prevents postmenopausal bone loss, decreases fracture in those with established postmenopausal osteoporosis, effectively treats Paget disease, and prevents corticosteroid-induced bone loss. Long-term toxic effects and efficacy, particularly fracture end point data, are unknown. Also undefined are optimal duration of therapy, potential for use in combination with other agents, and direct comparison with other bisphosphonates used for osteoporosis.

Animals↗