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Cummings S.R.,University of California at San Francisco | Cosman F.,Regional Bone Center | Cosman F.,Columbia University | Eastell R.,University of Sheffield | And 3 more authors.
Journal of Bone and Mineral Research | Year: 2013

Drug treatment for osteoporosis typically begins with an oral bisphosphonate, regardless of initial bone mineral density (BMD) or fracture risk, and decisions to continue or change treatment are often based on evidence of response to treatment based on changes in BMD, bone turnover markers, and occurrence of fractures. This pattern differs from preventive therapy for other conditions, such as hypertension, where treatment is based on achieving a goal. We propose that a goal be established to guide treatments to reduce fracture risk. The goal could be a certain risk of fracture or level of BMD. Goal-directed treatment would individualize the initial choice of treatment based on the probability that alternatives would achieve the patient's goal. In contrast to changing treatments based on years of use or failure to respond, the patient's BMD and risk would be reassessed periodically and decisions to stop or change treatment would be based on achieving or maximizing the chance of reaching an acceptable level of fracture risk or BMD. The acceptance of goal-directed treatment and application to practice will require a consensus on a number of issues about goals along with models of fracture risk while on treatment and probabilities of achieving goals. The result could be more rational and effective use of the expanding array of treatments for osteoporosis. © 2013 American Society for Bone and Mineral Research.


Jacques R.M.,University of Sheffield | Boonen S.,Catholic University of Leuven | Cosman F.,Regional Bone Center | Reid I.R.,University of Auckland | And 3 more authors.
Journal of Bone and Mineral Research | Year: 2012

Measurements of change in bone mineral density (BMD) are thought to be weak predictors of treatment effect on the reduction of fracture risk. In this study we report an alternative year-on-year approach for the estimation of treatment effect explained by BMD in which we examine the relationship between fracture risk and the most recent change in BMD. We studied 7736 postmenopausal women (ages 65 to 89 years) who were participants in the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT) and were randomized to either intravenous administration of zoledronic acid or placebo. The percentage of treatment effect explained by change in total hip BMD was estimated using the alternative year-on-year approach and the standard approach of looking at change over 3 years. We also studied a subset of 1132 women in whom procollagen type 1 amino-terminal propeptide (PINP) was measured at baseline and 12 months, to estimate the percentage of treatment effect explained by change in PINP. Regardless of the method used, the change in total hip BMD explained a large percentage of the effect of zoledronic acid in reducing new vertebral fracture risk (40%; 95% CI, 30% to 54%; for the 3-year analysis). The treatment effects for nonvertebral fracture were not statistically significant for the year-on-year analysis but 3-year change in BMD explained 61% (95% CI, 24% to 156%) of treatment effect. Change in PINP explained 58% (95% CI, 15% to 222%) of the effect of zoledronic acid in reducing new vertebral fracture risk. We conclude that our estimates of the percentage of treatment effect explained may be higher than in previous studies because of high compliance with zoledronic acid (due to its once-yearly intravenous administration). Previous studies may have underestimated the relationship between BMD change and the effect of treatment on fracture risk. Copyright © 2012 American Society for Bone and Mineral Research.


Lewiecki E.M.,New Mexico Clinical Research and Osteoporosis Center | Cummings S.R.,University of California at San Francisco | Cosman F.,Regional Bone Center | Cosman F.,Columbia University
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Objectives: Current clinical practice guidelines identify patients at high risk for fracture who are likely to benefit from pharmacological therapy and suggest ways to monitor for effectiveness of therapy. However, there is no clear guidance on when fracture risk has been reduced to an acceptably low level. As a consequence, some patients at low risk for fracture may be treated for longer than necessary, whereas others at high risk for fracture may have treatment stopped when they might benefit from continuation of the same treatment or a change to a more potent therapeutic agent. The objective of this statement is to describe the potential clinical utility of developing a "treat-to- target" strategy for the management of patients with osteoporosis. Participants: We recommend that a task force of clinicians, clinical investigators, and other stakeholders in the care of osteoporosis explore the options, review the evidence, and identify additional areas for investigation to establish osteoporosis treatment targets. Evidence: Data from large, prospective, randomized, placebo-controlled registration trials for currently available osteoporosis therapies should be analyzed for commonalities of correlations between easily measured endpoints and fracture risk. Consensus Process: Osteoporosis experts, professional organizations, and patient care advocates should be involved in the process of developing consensus on easily measurable osteoporosis treatment targets that are supported by the best available evidence and likely to be accepted by clinicians and patients in the care of osteoporosis. Conclusions: A treat-to-target strategy for osteoporosis offers the potential of improving osteoporosis care by reducing the burden of osteoporotic fractures and limiting adverse effects of therapy. Copyright © 2013 by The Endocrine Society.


Recker R.R.,Creighton University | Kimmel D.B.,Creighton University | Dempster D.,Regional Bone Center | Weinstein R.S.,University of Arkansas for Medical Sciences | And 2 more authors.
Bone | Year: 2011

This review reports on proceedings of a bone histomorphometry session conducted at the Fortieth International IBMS Sun Valley Skeletal Tissue Biology Workshop held on August 1, 2010. The session was prompted by recent technical problems encountered in conducting histomorphometry on bone biopsies from humans and animals treated with anti-remodeling agents such as bisphosphonates and RANKL antibodies. These agents reduce remodeling substantially, and thus cause problems in calculating bone remodeling dynamics using in vivo fluorochrome labeling. The tissue specimens often contain few or no fluorochrome labels, and thus create statistical and other problems in analyzing variables such as mineral apposition rates, mineralizing surface and bone formation rates. The conference attendees discussed these problems and their resolutions, and the proceedings reported here summarize their discussions and recommendations. © 2011 Elsevier Inc.


Walker M.D.,Columbia University | Dempster D.W.,Regional Bone Center | McMahon D.J.,Columbia University | Udesky J.,Columbia University | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: Current guidelines recommend parathyroidectomy in patients with primary hyperparathyroidism (PHPT) who have an estimated glomerular filtration rate (eGFR) less than 60 ml/min per 1.73 m2. It is unclear, however, whether values below this threshold of renal impairment affect bone and mineral metabolism in PHPT. Objective: The purpose of this study was to assess the effect of renal function on skeletal health in PHPT. Design: This is a retrospective analysis of PHPT patients with (eGFR < 60 ml/min per 1.73 m2) and without chronic kidney disease (CKD) from our previously described PHPT cohort recruited from 1984 to 1991. Setting: The study was conducted in a university hospital metabolic bone unit. Participants: One hundred thirty-eight women and men with PHPT were studied. Outcome Measures: We assessed bone mineral density (BMD) by dual-energy x-ray absorptiometry; quantitative histomorphometric indices from transiliac bone biopsies; and biochemical markers of mineral metabolism. Results: Although there was no difference in serum or urinary calcium or PTH level, calcitriol levels were lower and phosphate levels higher in patients with CKD. BMD adjusted for weight did not differ at any site between groups. Histomorphometric analysis (n = 30 of 138) revealed a 45% greater eroded surface in those with CKD (P = 0.02). Eroded surface negatively correlated with eGFR (r = -0.46, P = 0.02) and phosphate (r = -0.48, P= 0.02) and positively correlated with serum calcium level (r = 0.51, P = 0.009) but not with PTH, alkaline phosphatase, vitamin D metabolites, or urinary calcium excretion. Conclusion: Although cardinal biochemical indices (such as calcium and PTH) and BMD do not differ in PHPT patients with an eGFR below 60 ml/min per 1.73 m2, these patients have higher phosphate and histomorphometric evidence of altered bone remodeling compared with those without CKD. Copyright © 2012 by The Endocrine Society.

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