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Zoledronate administered every 12 to 18 months prevents fractures in older women. Ten years after initiation of this trial, zoledronate administered at baseline and 5 years prevented vertebral fracture.

Among postmenopausal women with osteoporosis and a high risk of fracture, treatment with the monoclonal antibody romosozumab for 12 months followed by alendronate resulted in a significantly lower risk of fracture than alendronate for 12 months followed by alendronate.

SummaryIn this randomized, controlled trial, treatment with once-weekly subcutaneous injection of teriparatide for 72 weeks was found to be associated with a significant reduction in the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.IntroductionTo determine whether the anti-fracture efficacy of teriparatide is superior to that of alendronate, a prospective, randomized, open-label, blinded-endpoint trial was performed.MethodsJapanese women aged at least 75 years were eligible for the study if they had primary osteoporosis and were at high risk of fracture. Patients were randomly assigned in a 1:1 ratio to receive sequential therapy (once-weekly subcutaneous injection of teriparatide 56.5 μg for 72 weeks followed by alendronate for 48 weeks) or monotherapy with alendronate for 120 weeks. The primary endpoint was the incidence of morphometric vertebral fractures at 72 weeks (at the end of teriparatide treatment).ResultsBetween October 2014 and December 2017, 1011 patients (505 in the teriparatide group and 506 in the alendronate group) were enrolled. Of these, 778 patients (351 and 427, respectively) were included in the primary analysis. The incidence of morphometric vertebral fractures was significantly lower in the teriparatide group (56 per 419.9 person-years, annual incidence rate 0.1334) than in the alendronate group (96 per 553.6 person-years, annual incidence rate 0.1734), with a rate ratio of 0.78 (95% confidence interval 0.61 to 0.99, P = 0.04). In both groups, adverse events were most frequently reported in the following system organ classes: infections and infestations, gastrointestinal disorders, and musculoskeletal and connective tissue disorders.ConclusionOnce-weekly subcutaneous injection of teriparatide significantly reduced the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture.Trial registrationjRCTs031180235 and UMIN000015573, March 12, 2019

Romosozumab binds sclerostin, increases bone formation, and decreases bone resorption. Postmenopausal women with osteoporosis were assigned to romosozumab or placebo for 1 year, followed by 1 year of denosumab. Romosozumab was associated with lower vertebral and clinical fracture risk. Osteoporosis can lead to fragility fractures, which result in clinical burden and increased mortality. 1 , 2 Even after a fracture, fewer than 25% of patients receive pharmacologic treatment for osteoporosis. 3 – 5 After the discovery that sclerostin deficiency causes rare genetic conditions that are characterized by high bone mass and resistance to fracture, 6 , 7 sclerostin became a therapeutic target for the treatment of osteoporosis. Sclerostin, a negative regulator of bone formation that is secreted by osteocytes, 8 inhibits Wnt signaling, down-regulating this stimulus for osteoblast development and function. 9 Romosozumab (Amgen and UCB Pharma) is a monoclonal antibody that binds and inhibits sclerostin, with . . .

In this trial, women between the ages of 60 and 90 with low bone mineral density received twice-yearly subcutaneous injections of denosumab, a fully human monoclonal antibody against the receptor activator of nuclear factor-κB ligand, which inhibits the development and activity of osteoclasts, or placebo. Denosumab was associated with a reduced risk of vertebral, nonvertebral, and hip fractures. Women between the ages of 60 and 90 with low bone mineral density received twice-yearly subcutaneous injections of denosumab, which inhibits the development and activity of osteoclasts, or placebo. Denosumab was associated with a reduced risk of vertebral, nonvertebral, and hip fractures. Fractures are a major cause of disability and health care costs. 1 , 2 The use of denosumab is a novel approach to fracture prevention. It is a fully human monoclonal antibody against the receptor activator of nuclear factor-κB ligand (RANKL), a cytokine that is essential for the formation, function, and survival of osteoclasts. 3 By binding RANKL, denosumab prevents the interaction of RANKL with its receptor, RANK, on osteoclasts and osteoclast precursors and reversibly inhibits osteoclast-mediated bone resorption. 4 In previous trials, the subcutaneous administration of 60 mg of denosumab every 6 months reduced bone turnover and increased bone mineral density. 5 – 8 We . . .

Summary We examined vertebral fracture (VF) prevalence, incidence, and treatment among 1488 older adults. VF prevalence and incidence were higher in women, older participants, and those with low bone density. In addition to VFs being underdiagnosed (only 20.7% of VFs clinically recognized), treatment rates were low, underscoring the need for improved screening and management. Purpose To estimate prevalence and incidence of osteoporotic VFs and VF progressions overall and by sex, age, and bone status and to describe the proportion of participants with VFs in reporting osteoporosis (OP) medication use. Methods This observational analysis of the DO-HEALTH trial, a three-year, randomized, controlled trial among community-dwelling adults age ≥ 70 years, includes a subsample of participants recruited at four study sites equipped with DXA machines. Prevalence and incidence rates (IR) of VFs and VF progressions were described overall and by subgroups of sex, age, and bone status. Incidence of VFs which were clinically recognized was also estimated. Further, we estimated the proportion of participants on OP medication. Results A total of 1488 participants were included (mean age 74.9 years, 63.1% women, 77.0% had osteopenia or osteoporosis). One hundred forty-four (9.7%) participants had at least one radiographic VF at baseline and of those 19.4% participants reported OP medication use. Over the three-year follow-up, 50 participants sustained 58 new radiographic VFs (IR 1.4, 95% CI 1.1, 1.9). Of the 58 radiographic VFs, only 12 (20.7%) were clinically recognized. Furthermore, 31 participants sustained 35 VF progressions ( N  = 157; IR 7.7, 95% CI 5.5, 10.7). Prevalence and incidence were significantly higher in women, in older participants and those with osteopenia or osteoporosis compared to those with normal bone density. Conclusions This study suggests a high prevalence and incidence of VFs in community-dwelling European older adults. Underdiagnosis may be even more prevalent than previously observed, and treatment rates were low.

Abstract Context The ACTIVE study demonstrated the antifracture efficacy of abaloparatide in postmenopausal women with osteoporosis. ACTIVExtend demonstrated sustained fracture risk reduction with alendronate in abaloparatide-treated participants from ACTIVE. A direct comparison of the efficacy of abaloparatide and antiresorptive therapies has not been performed. Objective The objective of this analysis is to compare the antifracture efficacy of abaloparatide in ACTIVE with that of alendronate in ACTIVExtend. Design In this post hoc analysis, the rate of new vertebral fractures for women in ACTIVExtend (N = 1139) was calculated based on baseline and endpoint radiographs for placebo or abaloparatide in ACTIVE and alendronate in ACTIVExtend. Vertebral fracture rates between abaloparatide and alendronate were compared in a Poisson regression model. Fracture rates for nonvertebral and clinical fractures were compared based on a Poisson model during 18 months of abaloparatide or placebo treatment in ACTIVE and 18 months of alendronate treatment in ACTIVExtend. Results The vertebral fracture rate was lower during abaloparatide treatment in ACTIVE (0.47 fractures/100 patient-years) than alendronate treatment in ACTIVExtend (1.66 fractures/100 patient-years) (relative risk reduction 71%; P = .027). Although the comparisons did not meet statistical significance, after switching from placebo (ACTIVE) to alendronate (ACTIVExtend), the rate of new vertebral fractures decreased from 2.49 to 1.66 fractures per 100 patient-years, and after switching from abaloparatide to alendronate from 0.47 to 0.19 fractures per 100 patient-years. The rates of nonvertebral fractures and clinical fractures were not significantly different. Conclusion Initial treatment with abaloparatide may result in greater vertebral fracture reduction compared with alendronate in postmenopausal women with osteoporosis.

Summary The association of renal function with fracture incidence during teriparatide or alendronate treatment in elderly Japanese women was examined. Fracture incidence differed by fracture type, renal function, and treatment protocol. The results provide important information on pharmacotherapy in clinical practice for osteoporosis. Purpose Incidence rate of morphometric vertebral fracture was lower under treatment with once-weekly teriparatide (TPTD) followed by alendronate (ALN) than under treatment with ALN throughout the study among elderly Japanese women at high fracture risk in JOINT-05. This is an exploratory subgroup analysis according to chronic kidney disease (CKD) status at baseline. Methods Participants received sequential therapy with TPTD for 72 weeks, followed by ALN for 48 weeks (TPTD-ALN group, N  = 483) or ALN monotherapy for 120 weeks (ALN group, N  = 496). Baseline CKD status was classified by the estimated glomerular filtration rate (eGFR) and categorized as: CKD 1/2 (eGFR ≥ 60 mL/min/1.73 m 2 ), CKD 3a (eGFR 45–59 mL/min/1.73 m 2 ), or CKD 3b/4 (eGFR < 45 mL/min/1.73 m 2 ). Incidences of vertebral fractures including morphometric fractures, non-vertebral fractures, and all fractures were evaluated during follow-up. Results Baseline characteristics were not different between treatment groups. Higher stages of CKD were associated with age and number of prevalent vertebral fracture. In CKD 1/2 patients ( N  = 556 with 90 incidents of morphometric vertebral fracture), the incidence of vertebral fractures was lower in the TPTD-ALN group than in the ALN group ( p  = 0.01). In CKD 3b/4 patients ( N  = 112 with 10 incidents of non-vertebral fracture), the incidence of non-vertebral fractures was lower in the ALN group than in the TPTD-ALN group, although the number of fractures was small. In the ALN group, the incidences of vertebral fractures, non-vertebral fractures, and all fractures remained constant across CKD stages. Conclusion This exploratory analysis showed that fracture incidence on ALN was constant regardless of renal function. It also suggested that the incidence of vertebral fractures on TPTD-ALN was lower than ALN monotherapy in CKD 1/2 patients. These results provide important information for drug selection in the clinical practice of osteoporosis.

In this double-blind, placebo-controlled trial, women with postmenopausal osteoporosis received an infusion of either zoledronic acid (5 mg) or placebo at baseline and at 1 and 2 years and were followed for 3 years. Zoledronic acid significantly reduced the risk of vertebral, hip, and other fractures. Adverse events were similar in the two study groups, except for serious atrial fibrillation, which was more frequent in the zoledronic acid group. This drug may provide a promising approach to reducing fracture risk. In women with postmenopausal osteoporosis, zoledronic acid significantly reduced the risk of vertebral, hip, and other fractures. This drug may provide a promising approach to reducing fracture risk. Fractures are an important cause of disability among postmenopausal women, and the costs of medical care associated with osteoporosis are estimated to be more than $18 billion annually in the United States alone. 1 Bisphosphonates, the most commonly used treatment for established osteoporosis, inhibit osteoclast-mediated bone resorption and reduce the risk of vertebral fracture. Two bisphosphonates, alendronate and risedronate, also have been shown to reduce nonvertebral and hip fractures in women with osteoporosis. 2 – 6 However, adherence to oral treatment is problematic, and about half of patients for whom oral treatment is prescribed do not adhere to it after 1 year. 7 , . . .

Women between 59 and 80 years of age with a bone mineral density T score of –2.5 or less at the femoral neck or spine received the selective estrogen-receptor modulator lasofoxifene (either 0.25 or 0.5 mg daily) or placebo for 5 years. Lasofoxifene was associated with lower risks of fractures, estrogen-receptor–positive breast cancer, coronary heart disease, and stroke, with no increase in endometrial cancer, but there was an increase in venous thromboembolic events. In women with osteoporosis, lasofoxifene was associated with lower risks of fractures, estrogen-receptor–positive breast cancer, coronary heart disease, and stroke, with no increase in endometrial cancer, but there was an increase in venous thromboembolic events. Lasofoxifene is a nonsteroidal selective estrogen-receptor modulator that decreases bone resorption, bone loss, and low-density- lipoprotein (LDL) cholesterol in postmenopausal women. 1 We conducted the Postmenopausal Evaluation and Risk-Reduction with Lasofoxifene (PEARL) trial to determine whether lasofoxifene would reduce the risk of fractures, estrogen receptor (ER)–positive breast cancer, and cardiovascular disease among postmenopausal women with osteoporosis. Methods Study Design The PEARL trial was an international, randomized, placebo-controlled trial. Subjects received 1 g of calcium and 400 to 800 IU of vitamin D and placebo during a 6- to 8-week run-in period; women who received 75% or more of these pills were . . .