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Dr. Marc Wein: Clinicians should consider increase in atrial fibrillation risk in the setting of other cardiac comorbidities when selecting anti-resorptive therapy for osteoporosis
Dr. Wein scans the journals, so you don't have to!

As first line agents for fracture risk reduction in osteoporosis, bisphosphonates are generally well-tolerated and safe medications. Zoledronic acid (ZA) is a commonly-used bisphosphonate due to its proven skeletal benefits, lack of gastrointestinal side effects, and ease of administration by annual intravenous infusion. Some previous placebo-controlled randomized trials with ZA demonstrated a small increased risk of potentially-serious atrial fibrillation. In this new-user, active comparator study, investigators used real world clinical data to explore the relationship between ZA use and incident atrial fibrillation. Propensity score matching was used to obtain well-balanced comparison groups of patients starting ZA or denosumab (another potent anti-resorptive agent not previously linked to atrial fibrillation) therapy. Importantly, the authors investigated one cohort where these medications were prescribed for osteoporosis and a second cohort where ZA or denosumab were started for oncologic indications. In both cohorts, ZA therapy was associated with a modestly increased risk of incident atrial fibrillation. These data confirm previous findings from smaller, randomized controlled trials in a large (~47,000 patients) real world claims-based dataset. Clinicians should consider this modest increase in atrial fibrillation risk in the setting of other cardiac comorbidities when selecting anti-resorptive therapy for osteoporosis. At the mechanistic level, very little is known about how zoledronic acid might contribute to atrial fibrillation risk. Since denosumab was used as an active comparator, these results argue against a mechanism of systemic calcium shifts due to suppressed bone resorption. Further studies are needed to assess if ZA has direct effects on cardiac tissue. 


Bariatric surgery rates continue to climb in the setting of increasing obesity throughout the world. While effective at promoting weight loss, a growing body of literature has clearly demonstrated that bone loss and increased fracture risk occurs following bariatric surgery. However, major important questions remain regarding the impact of specific types of bariatric surgery on bone metabolism. Notably, most previous studies were not performed in a randomized manner with respect to the type of weight loss surgery. As such, indication bias exists with respect to current knowledge regarding how specific weight loss surgeries impact bone. Here, a randomized, triple-blind single center study in Norway assessed skeletal endpoints in patients with severe obesity and type 2 diabetes who were randomized to receive either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy weight loss surgery. The primary focus of this study, reported elsewhere, was to assess rates of diabetes remission. Areal bone mineral density in the hip and spine decreased significantly more one year after RYGB than after sleeve gastrectomy. The authors investigated serum bone turnover markers over time in these subjects. Both forms of bariatric surgery led to increases in bone formation and resorption markers, with higher levels of both markers seen after RYGB than sleeve gastrectomy. Importantly, these effects were independently associated with surgical procedure and not resultant weight change. Findings here strongly support the emerging notion that RYGB in particular is linked to high bone turnover and bone loss. While many hypotheses exist as to the underlying mechanism linking RYBG and bone loss, this remains an active and open area of investigation.

Denosumab, a neutralizing antibody against RANKL, is a potent antiresorptive agent that increases bone density and reduces fracture risk. In addition to its major role in osteoclast development, the paracrine-acting cytokine RANKL plays an important role in development and maintenance of the adaptive immune system. As such, a concern has been raised that denosumab treatment may increase risk of malignancies kept at bay by lymphoid surveillance. In this systematic review and meta-analysis of randomized controlled trials, the authors assessed risk of malignancy of denosumab versus comparator in 25 prospective randomized controlled trials. In these trials, >21,000 patients were analyzed who were treated for osteoporosis with either denosumab or control. The risk of malignancy was similar between osteoporosis denosumab dosing (60 mg every 6 months) and control. Drug exposure in these studies was up to 48 months. As such, additional post-marketing surveillance safety data are needed to address longer-term risks of malignancy. Nonetheless, these data are largely reassuring and provide additional evidence of the safety of denosumab therapy for osteoporosis.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

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Dr. Wein scans the journals, so you don't have to!
Dr. Wein scans the journals, so you don't have to!

As first line agents for fracture risk reduction in osteoporosis, bisphosphonates are generally well-tolerated and safe medications. Zoledronic acid (ZA) is a commonly-used bisphosphonate due to its proven skeletal benefits, lack of gastrointestinal side effects, and ease of administration by annual intravenous infusion. Some previous placebo-controlled randomized trials with ZA demonstrated a small increased risk of potentially-serious atrial fibrillation. In this new-user, active comparator study, investigators used real world clinical data to explore the relationship between ZA use and incident atrial fibrillation. Propensity score matching was used to obtain well-balanced comparison groups of patients starting ZA or denosumab (another potent anti-resorptive agent not previously linked to atrial fibrillation) therapy. Importantly, the authors investigated one cohort where these medications were prescribed for osteoporosis and a second cohort where ZA or denosumab were started for oncologic indications. In both cohorts, ZA therapy was associated with a modestly increased risk of incident atrial fibrillation. These data confirm previous findings from smaller, randomized controlled trials in a large (~47,000 patients) real world claims-based dataset. Clinicians should consider this modest increase in atrial fibrillation risk in the setting of other cardiac comorbidities when selecting anti-resorptive therapy for osteoporosis. At the mechanistic level, very little is known about how zoledronic acid might contribute to atrial fibrillation risk. Since denosumab was used as an active comparator, these results argue against a mechanism of systemic calcium shifts due to suppressed bone resorption. Further studies are needed to assess if ZA has direct effects on cardiac tissue. 


Bariatric surgery rates continue to climb in the setting of increasing obesity throughout the world. While effective at promoting weight loss, a growing body of literature has clearly demonstrated that bone loss and increased fracture risk occurs following bariatric surgery. However, major important questions remain regarding the impact of specific types of bariatric surgery on bone metabolism. Notably, most previous studies were not performed in a randomized manner with respect to the type of weight loss surgery. As such, indication bias exists with respect to current knowledge regarding how specific weight loss surgeries impact bone. Here, a randomized, triple-blind single center study in Norway assessed skeletal endpoints in patients with severe obesity and type 2 diabetes who were randomized to receive either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy weight loss surgery. The primary focus of this study, reported elsewhere, was to assess rates of diabetes remission. Areal bone mineral density in the hip and spine decreased significantly more one year after RYGB than after sleeve gastrectomy. The authors investigated serum bone turnover markers over time in these subjects. Both forms of bariatric surgery led to increases in bone formation and resorption markers, with higher levels of both markers seen after RYGB than sleeve gastrectomy. Importantly, these effects were independently associated with surgical procedure and not resultant weight change. Findings here strongly support the emerging notion that RYGB in particular is linked to high bone turnover and bone loss. While many hypotheses exist as to the underlying mechanism linking RYBG and bone loss, this remains an active and open area of investigation.

Denosumab, a neutralizing antibody against RANKL, is a potent antiresorptive agent that increases bone density and reduces fracture risk. In addition to its major role in osteoclast development, the paracrine-acting cytokine RANKL plays an important role in development and maintenance of the adaptive immune system. As such, a concern has been raised that denosumab treatment may increase risk of malignancies kept at bay by lymphoid surveillance. In this systematic review and meta-analysis of randomized controlled trials, the authors assessed risk of malignancy of denosumab versus comparator in 25 prospective randomized controlled trials. In these trials, >21,000 patients were analyzed who were treated for osteoporosis with either denosumab or control. The risk of malignancy was similar between osteoporosis denosumab dosing (60 mg every 6 months) and control. Drug exposure in these studies was up to 48 months. As such, additional post-marketing surveillance safety data are needed to address longer-term risks of malignancy. Nonetheless, these data are largely reassuring and provide additional evidence of the safety of denosumab therapy for osteoporosis.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

As first line agents for fracture risk reduction in osteoporosis, bisphosphonates are generally well-tolerated and safe medications. Zoledronic acid (ZA) is a commonly-used bisphosphonate due to its proven skeletal benefits, lack of gastrointestinal side effects, and ease of administration by annual intravenous infusion. Some previous placebo-controlled randomized trials with ZA demonstrated a small increased risk of potentially-serious atrial fibrillation. In this new-user, active comparator study, investigators used real world clinical data to explore the relationship between ZA use and incident atrial fibrillation. Propensity score matching was used to obtain well-balanced comparison groups of patients starting ZA or denosumab (another potent anti-resorptive agent not previously linked to atrial fibrillation) therapy. Importantly, the authors investigated one cohort where these medications were prescribed for osteoporosis and a second cohort where ZA or denosumab were started for oncologic indications. In both cohorts, ZA therapy was associated with a modestly increased risk of incident atrial fibrillation. These data confirm previous findings from smaller, randomized controlled trials in a large (~47,000 patients) real world claims-based dataset. Clinicians should consider this modest increase in atrial fibrillation risk in the setting of other cardiac comorbidities when selecting anti-resorptive therapy for osteoporosis. At the mechanistic level, very little is known about how zoledronic acid might contribute to atrial fibrillation risk. Since denosumab was used as an active comparator, these results argue against a mechanism of systemic calcium shifts due to suppressed bone resorption. Further studies are needed to assess if ZA has direct effects on cardiac tissue. 


Bariatric surgery rates continue to climb in the setting of increasing obesity throughout the world. While effective at promoting weight loss, a growing body of literature has clearly demonstrated that bone loss and increased fracture risk occurs following bariatric surgery. However, major important questions remain regarding the impact of specific types of bariatric surgery on bone metabolism. Notably, most previous studies were not performed in a randomized manner with respect to the type of weight loss surgery. As such, indication bias exists with respect to current knowledge regarding how specific weight loss surgeries impact bone. Here, a randomized, triple-blind single center study in Norway assessed skeletal endpoints in patients with severe obesity and type 2 diabetes who were randomized to receive either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy weight loss surgery. The primary focus of this study, reported elsewhere, was to assess rates of diabetes remission. Areal bone mineral density in the hip and spine decreased significantly more one year after RYGB than after sleeve gastrectomy. The authors investigated serum bone turnover markers over time in these subjects. Both forms of bariatric surgery led to increases in bone formation and resorption markers, with higher levels of both markers seen after RYGB than sleeve gastrectomy. Importantly, these effects were independently associated with surgical procedure and not resultant weight change. Findings here strongly support the emerging notion that RYGB in particular is linked to high bone turnover and bone loss. While many hypotheses exist as to the underlying mechanism linking RYBG and bone loss, this remains an active and open area of investigation.

Denosumab, a neutralizing antibody against RANKL, is a potent antiresorptive agent that increases bone density and reduces fracture risk. In addition to its major role in osteoclast development, the paracrine-acting cytokine RANKL plays an important role in development and maintenance of the adaptive immune system. As such, a concern has been raised that denosumab treatment may increase risk of malignancies kept at bay by lymphoid surveillance. In this systematic review and meta-analysis of randomized controlled trials, the authors assessed risk of malignancy of denosumab versus comparator in 25 prospective randomized controlled trials. In these trials, >21,000 patients were analyzed who were treated for osteoporosis with either denosumab or control. The risk of malignancy was similar between osteoporosis denosumab dosing (60 mg every 6 months) and control. Drug exposure in these studies was up to 48 months. As such, additional post-marketing surveillance safety data are needed to address longer-term risks of malignancy. Nonetheless, these data are largely reassuring and provide additional evidence of the safety of denosumab therapy for osteoporosis.

Marc Wein, M.D., Ph.D
Assistant Professor of Medicine
Massachusetts General Hospital Endocrine Unit, Harvard Medical School

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Dr. Marc Wein: Clinicians should consider increase in atrial fibrillation risk in the setting of other cardiac comorbidities when selecting anti-resorptive therapy for osteoporosis
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