Context: Current osteoporosis medications increase bone mineral density (BMD) modestly and reduce, but do not eliminate, fracture risk. Attempts to improve efficacy by administering anabolic agents and bisphosphonates concomitantly have been unsuccessful. Conversely, 12 months of concomitant denosumab and teriparatide therapy increases BMD more than either drug alone. Objective: The purpose of this study was to determine whether 24 months of combined denosumab and teriparatide will increase hip and spine BMD more than either individual agent. Design: Preplanned continuation of the Denosumab and Teriparatide Administration (DATA) randomized controlled trial in which postmenopausal osteoporotic women received teriparatide (20 μg daily), denosumab (60 mg every 6 months), or both medications for 24 months. Participants: Participants were 94 postmenopausal women with osteoporosis. Outcome Measures: Lumbar spine, femoral neck, total hip, and distal radius BMD and serum markers of bone turnover were measured. Re...

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Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women With Osteoporosis (The DATA Extension Study): A Randomized Controlled Trial

Atherosclerosis and osteoporosis are chronic diseases that progress with age, and studies suggest aortic calcification, an indicator of atherosclerosis, is inversely associated with BMD. The OPG/RANK/RANKL system has been proposed as a shared regulatory system for bone and vasculature. Denosumab (DMAb), a monoclonal antibody against RANKL, improved BMD and reduced fracture risk in the FREEDOM trial. We evaluated whether or not treatment with DMAb influenced progression of aortic calcification (AC) and incidence of cardiovascular (CV) adverse events. We included 2,363 postmenopausal women with osteoporosis (1,142 placebo, 1,221 DMAb), selected from 7,808 participants in the FREEDOM trial (3,906 placebo, 3,902 DMAb), at high risk of CV events according to modified Raloxifene Use for the Heart (RUTH) criteria. CV adverse events were reported by participants. AC scores were assessed using a semi-quantitative method from lateral spine x-rays. Change in AC score from baseline to 12 (N = 1,377), 24 (N = 1,231) and 36 months (N = 1,045) was calculated as AC score at follow-up minus AC score at baseline. AC progression was defined as change in AC score > 0. Baseline characteristics, CV risk factors, and AC scores were similar between treatment groups. Mean age of participants was 74 years (range, 60–90), 88% were white, and 77% had AC score > 0 at baseline. Frequency of AC progression over 3 years did not differ between women in placebo (22%) and DMAb (22%) groups (p = 0.98). AC progression did not differ between treatment groups when analyzed by baseline estimated glomerular filtration rate or by baseline AC scores. Frequency of CV adverse events did not differ between placebo (40%) and DMAb (38%) groups (p = 0.26). In conclusion, DMAb treatment had no effect on progression of AC or incidence of CV adverse events compared to placebo.

RANKL inhibition with denosumab does not influence 3-year progression of aortic calcification or incidence of adverse cardiovascular events in postmenopausal women with osteoporosis and high cardiovascular risk

Objective To provide guidelines for the health care provider on the prevention, diagnosis, and clinical management of postmenopausal osteoporosis. Outcomes Strategies for identifying and evaluating high-risk individuals, the use of bone mineral density (BMD) and bone turnover markers in assessing diagnosis and response to management, and recommendations regarding nutrition, physical activity, and the selection of pharmacologic therapy to prevent and manage osteoporosis. Evidence Published literature was retrieved through searches of PubMed and The Cochrane Library on August 30 and September 18, 2012, respectively. The strategy included the use of appropriate controlled vocabulary (e.g., oteoporosis, bone density, menopause) and key words (e.g., bone health, bone loss, BMD). Results were restricted to systematic reviews, practice guidelines, randomized and controlled clinical trials, and observational studies published in English or French. The search was limited to the publication years 2009 and following, and updates were incorporated into the guideline to March 2013. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Values The quality of the evidence was rated using the criteria described by the Canadian Task Force on Preventive Health Care (Table). Sponsors The Society of Obstetricians and Gynaecologists of Canada.

Osteoporosis in Menopause

BACKGROUND Approximately 30% of patients with Crohn disease (CD) are unresponsive to biologics. No previous study has focused on a plant-based diet in an induction phase of CD treatment. OBJECTIVE To investigate the remission rate of infliximab combined with a plant-based diet as first-line (IPF) therapy for CD. METHODS This was a prospective single-group trial conducted at tertiary hospitals. Subjects included consecutive adults with a new diagnosis (n = 26), children with a new diagnosis (n = 11), and relapsing adults (n = 9) with CD who were naive to treatment with biologics. Patients were admitted and administered a standard induction therapy with infliximab (5 mg/kg; 3 infusions at 0, 2, and 6 weeks). Additionally, they received a lacto-ovo-semivegetarian diet. The primary end point was remission, defined as the disappearance of active CD symptoms at week 6. Secondary end points were Crohn Disease Activity Index (CDAI) score, C-reactive protein (CRP) concentration, and mucosal healing. RESULTS Two adults with a new diagnosis were withdrawn from the treatment protocol because of intestinal obstruction. The remission rates by the intention-to-treat and per-protocol analyses were 96% (44/46) and 100% (44/44), respectively. Mean CDAI score (314) on admission decreased to 63 at week 6 (p < 0.0001). Mean CRP level on admission (5.3 mg/dL) decreased to 0.2 (p < 0.0001). Mucosal healing was achieved in 46% (19/41) of cases. CONCLUSION IPF therapy can induce remission in most patients with CD who are naive to biologics regardless of age or whether they have a new diagnosis or relapse.

Induction with Infliximab and a Plant-Based Diet as First-Line (IPF) Therapy for Crohn Disease: A Single-Group Trial.

Bone regeneration in osteoporosis: opportunities and challenges

Denosumab is a fully human monoclonal antibody against the receptor activator of the cytokine, nuclear factor-κB ligand, which is of critical importance for the formation, function, and survival of osteoclasts. This antibody binds nuclear factor-κB ligand and reversibly inhibits osteoclast-mediated bone resorption in osteoclasts and osteoclast precursors. Earlier studies reported that subcutaneous administration of denosumab every 6 months reduced bone turnover and increased bone mineral density. This international, randomized, placebo-controlled trial evaluated the effect of denosumab on the risk of fracture in 7808 postmenopausal women with osteoporosis. Participants had a bone mineral density T score less than -2.5 at the lumbar spine or total hip. Women with T scores less than -4.0 were excluded. Their ages ranged from 60 to 90 years. The study subjects used in the final analysis had been randomized to receive subcutaneous injections of 60 mg of denosumab (n = 3902) or placebo (n = 3906) every 6 months for 36 months. A new vertebral fracture was the primary outcome. The occurrence of nonvertebral fracture and hip fracture were the secondary end points. At 36-months, the cumulative incidence of new radiographic vertebral fracture was reduced by 68% in the denosumab group compared to the placebo group (denosumab: 2.3% vs. placebo: 7.2%); the risk ratio was 0.32, with a 95% confidence interval [CI] of 0.26-0.41; P < 0.001). The risk of hip fracture was reduced by 40% with the drug compared to the placebo group (cumulative incidence of denosumab: 0.7% vs. placebo: 1.2%); the hazard ratio was 0.60, with a 95% CI of 0.37-0.97; P = 0.04. Similarly, denosumab reduced the cumulative incidence of nonvertebral fracture from 8.0% in the placebo group to 6.5% in the denosumab group (hazard ratio, 0.80; 95% CI, 0.67-0.95; P = 0.01)-a 20% relative reduction in risk. During the 36-months of the study, denosumab was not associated with a significant increase in the incidence of infection, cancer, or cardiovascular events. No increase was found in the occurrence of delayed fracture healing or hypocalcemia and other adverse effects associated with potent antiresorptive agents. Osteonecrosis of the jaw was not observed in either group. These findings show that subcutaneous injections of denosumab every 6 months for 36 months is associated with a significant reduction in the risk of vertebral, hip, and nonvertebral fractures among postmenopausal women with osteoporosis.

Denosumab for prevention of fractures in postmenopausal women with osteoporosis. Editorial comment

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Denosumab for prevention of fractures in postmenopausal women with osteoporosis. Editorial comment