Pharmacologic treatment is recommended for postmenopausal women who have bone density T-scores (standard deviations from normal mean values in the spine, femoral neck, total hip, or distal radius) of -2.5 or below, T-scores between -1.0 and -2.5 with a history of fragility (low-trauma) fracture of the hip or spine, or T-scores between -1.0 and -2.5 with a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture.

View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis

US guidelines recommend pharmacologic therapy for postmenopausal women with a bone density T-score (standard deviation from normal mean values in healthy young women) of -2.5 or below in the lumbar spine, femoral neck, total hip, or distal radius, a T-score between -1.0 and -2.5 and a history of fragility (low-trauma) fracture of the hip or spine, or a T-score between -1.0 and -2.5 and a FRAX 10-year probability of ≥3% for hip fracture or ≥20% for major osteoporotic fracture (hip, clinical spine, humerus, distal radius).

View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis

The FDA has approved romosozumab-aqqg (Evenity – Amgen), a sclerostin inhibitor, for once-monthly subcutaneous (SC) treatment of osteoporosis in postmenopausal women who are at high risk for fracture (history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or cannot tolerate other drugs for this indication. Romosozumab is the first sclerostin inhibitor to be approved in the US and the third drug for treatment of postmenopausal osteoporosis that stimulates bone formation; the parathyroid hormone (PTH) receptor agonists abaloparatide (Tymlos) and teriparatide (Forteo) were approved earlier. Other drugs used for treatment of postmenopausal osteoporosis, such as bisphosphonates, inhibit bone resorption and decrease bone turnover.

Diagnosis of osteoporosis is based on the results of bone mineral density (BMD) testing or by the occurrence of a fragility fracture. Bone densitometry results are generally reported in terms of standard deviations (SD) from the mean value for young adults (T-score). The World Health Organization (WHO) defines osteoporosis in women as a T-score of -2.5 or below in the spine, femoral neck, or total hip. A computerized model (FRAX) is available that estimates the 10-year probability of a hip fracture or other major osteoporotic fracture based on clinical risk factors and BMD at the femoral neck.

View the Comparison Table: Drugs for Postmenopausal Osteoporosis

View the Comparison Table: Drugs for Postmenopausal Osteoporosis

US guidelines for the treatment of osteoporosis have been published. The diagnosis of osteoporosis has traditionally been established by the occurrence of fragility fractures or by bone densitometry, which is generally reported in terms of standard deviations (SD) from mean values in young adults (T-score). The World Health Organization (WHO) has defined normal bone mineral density (BMD) for women as a value within one SD of the young adult mean. Values 2.5 SD or more below the mean (T-score -2.5 or below) at the spine, femoral neck, or total hip are defined as osteoporosis. The WHO has developed a computerized model (FRAX) that predicts the 10-year probability of a hip fracture or other major osteoporotic fracture based on clinical risk factors and BMD at the femoral neck.

A new effervescent formulation of alendronate (Binosto – Mission) was recently approved by the FDA for treatment of osteoporosis. The new 70-mg effervescent tablet is considered bioequivalent to the usual 70-mg tablet formulations of alendronate (Fosamax, and generics), which are difficult to swallow and can cause esophageal injury.1 No published studies of the new formulation are available.

LABELING — The new strawberry-flavored effervescent tablet should be dissolved over at least 5 minutes in 4 ounces of water (not mineral or flavored water) and stirred for 10 seconds before drinking. As with tablet formulations of alendronate, the labeling of the effervescent solution says it should be taken once each week in the morning upon rising for the day, at least 30 minutes before eating, drinking or taking other medications, and the patient should remain upright during that interval.

COST — A monthly 4-pack of 70-mg Binosto tablets costs $140.2 A monthly supply of 4 generic 70-mg alendronate tablets costs $9.99 at some large discount pharmacies.

CONCLUSION — Binosto is an expensive new effervescent tablet formulation of alendronate that is dissolved in water and taken as a solution. The solution should be easier to swallow than the regular tablets and theoretically might be better tolerated, but no comparative studies are available.

1. Drugs for postmenopausal osteoporosis. Treat Guidel Med Lett 2011; 9:67.

2. Wholesale acquistion cost (WAC). Source: PricePointRx™ October 5, 2012. Reprinted with permission by FDB, Inc. All rights reserved. ©2012. http://www.firstdatabank.com/support/drug-pricing-policy.aspx. Actual retail prices may be higher.

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