Risa Kagan

Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study.

Once‐weekly alendronate 70 mg and once‐weekly risedronate 35 mg are indicated for the treatment of postmenopausal osteoporosis. These two agents were compared in a 12‐month head‐to‐head trial. Greater gains in BMD and greater reductions in markers of bone turnover were seen with alendronate compared with risedronate with similar tolerability.

Efficacy of tissue-selective estrogen complex of bazedoxifene/conjugated estrogens for osteoporosis prevention in at-risk postmenopausal women

OBJECTIVE To evaluate the efficacy of the tissue-selective estrogen complex, bazedoxifene/conjugated estrogens (BZA/CE), for postmenopausal osteoporosis prevention. DESIGN Multicenter, randomized, double-blind, placebo- and active-controlled, phase 3 trial (Selective estrogen Menopause And Response to Therapy [SMART]-1). SETTING Outpatient clinical study. PATIENT(S) Women (n = 3,397) more than 5 years and 1-5 years postmenopause were enrolled in the Osteoporosis Prevention I and II Substudies, respectively. INTERVENTION(S) Single tablets of BZA (10, 20, or 40 mg) each with CE (0.625 or 0.45 mg), raloxifene (60 mg), or a placebo taken daily for 2 years. MAIN OUTCOME MEASURE(S) The primary outcome for both substudies was change in bone mineral density of the lumbar spine; bone mineral density was also measured at the hip. RESULT(S) In both substudies, bone mineral density increased significantly more with all BZA/CE doses compared with placebo at the lumbar spine and total hip, and for most BZA/CE doses compared with raloxifene at the lumbar spine. Osteocalcin and N-telopeptide significantly decreased with all BZA/CE doses vs. placebo and most BZA/CE doses vs. raloxifene. CONCLUSION(S) BZA/CE combinations decreased bone turnover and bone loss in postmenopausal women at increased risk for osteoporosis.

The North American Menopause Society recommendations for clinical care of midlife women

In celebration of the 25th anniversary of The North American Menopause Society (NAMS), the Society has compiled a set of key points and clinical recommendations for the care of midlife women. NAMS has always been a premier source of information about menopause for both healthcare providers and midli

Burden of Illness for Osteoporotic Fractures Compared With Other Serious Diseases Among Postmenopausal Women in the United States

OBJECTIVES To provide a national estimate of the incidence of hospitalizations due to osteoporotic fractures (OFs) in women; compare this with the incidence of myocardial infarction (MI), stroke, and breast cancer; and assess temporal trends in the incidence and length of hospitalizations. PATIENTS AND METHODS The study included all women 55 years and older at the time of admission, admitted to a hospital participating in the US Nationwide Inpatient Sample for an outcome of interest. We performed a retrospective analysis of hospitalizations for OFs (hip, forearm, spine, pelvis, distal femur, wrist, and humerus), MI, stroke, or breast cancer, using the US Nationwide Inpatient Sample, 2000-2011. RESULTS From 2000 to 2011, there were 4.9 million hospitalizations for OF, 2.9 million for MI, 3.0 million for stroke, and 0.7 million for breast cancer. Osteoporotic fractures accounted for more than 40% of the hospitalizations in these 4 outcomes, with an age-adjusted rate of 1124 admissions per 100,000 person-years. In comparison, MI, stroke, and breast cancer had age-adjusted incidence rates of 668, 687, and 151 admissions per 100,000 person-years, respectively. The annual total population facility-related hospital cost was highest for hospitalizations due to OFs (

Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis.

5.1 billion), followed by MI (

Why the product labeling for low-dose vaginal estrogen should be changed

4.3 billion), stroke (

Route of delivery for patients with immune thrombocytopenic purpura

3.0 billion), and breast cancer (

Algorithm and mobile app for menopausal symptom management and hormonal/non-hormonal therapy decision making: a clinical decision-support tool from The North American Menopause Society.

0.5 billion). CONCLUSION These data provide evidence that in US women 55 years and older, the hospitalization burden of OFs and population facility-related hospital cost is greater than that of MI, stroke, or breast cancer. Prioritization of bone health and supporting programs such as fracture liaison services is needed to reduce this substantial burden.

Goal-Directed Treatment for Osteoporosis: A Progress Report from the ASBMR-NOF Working Group on Goal-Directed Treatment for Osteoporosis.

SUMMARY Objective: The FACT study (Fosamax Actonel Comparison Trial) was a 1-year head-to-head trial comparing the efficacy and tolerability of once weekly (OW) alendronate 70 mg and OW risedronate 35 mg for the treatment of postmenopausal osteoporosis. The present analysis was performed to determine the percentage of patients who had changes during the study in BMD and biochemical markers (BCMs) of bone turnover above or below specific cut-off points. A subgroup analysis of upper gastrointestinal (UGI) tolerability was also performed. Research design and methods: 1053 postmenopausal women with low BMD were randomized to alendronate 70 mg OW (N = 520) or risedronate 35 mg OW (N = 533). The percentage of patients who had measured BMD gains ≥ 0%, ≥ 3%, and ≥ 5% after 12 months at the hip trochanter, total hip, femoral neck, and lumbar spine (LS) was analyzed. The percentage of patients who experienced any bone loss, and those with measured losses of 3% or more at these sites after 12 months, was determined. The percentage of patients achieving reductions in urinary N-telopeptide of type I human collagen (NTX) ≥ 40%, and serum C-telopeptide of type I collagen (CTx) ≥ 60%, bone-specific alkaline phosphatase (BSAP) ≥ 30%, and N terminal propeptide of type I procollagen (P1NP) ≥ 50% at 3 months and 12 months was also determined. Tolerability, based on adverse experience reporting, was evaluated in a subgroup of patients with a history of UGI disorders at baseline. Results: A greater percentage of alendronate- than risedronate-treated patients had measured BMD gains (≥ 0%) ( p < 0.05) at all sites at 12 months. Significantly more ( p < 0.01) alendronate- than risedronate-treated patients had measured gains in BMD ≥ 3% and ≥ 5% at the hip trochanter, total hip, and LS spine. Significantly more ( p < 0.05) risedronate- than alendronate-treated patients had an apparent loss of BMD (> 0% and ≥ 3% loss) at these same sites. After 3 months, significantly ( p < 0.001) more alendronate- than risedronate-treated patients achieved predefined reductions in all BCMs. Similar tolerability was demonstrated in both treatment groups, regardless of whether or not patients had a history of UGI disorders at baseline. Conclusions: Significantly more alendronate- than risedronate-treated patients achieved predefined increases in BMD at 12 months and reductions in BCMs at 3 months. Significantly more risedronate- than alendronate-treated patients were classified as apparent ‘non-responders’ (i.e. experienced any bone loss) after 12 months of therapy. The tolerability profiles of the two medications were similar.

Bone turnover marker profile in relation to the menstrual cycle of premenopausal healthy women.

This commentary summarizes the activities of several clinicians and researchers to encourage modifications to the labeling of low-dose vaginal estrogen. Motivated by concerns of practicing clinicians that the boxed warning on the labels and package inserts for these products overstate potential risk