The Exchange

Commentary and Observations from
the Medical Front Lines

Prime Time for Osteoanabolic Therapy

Prime Time for Osteoanabolic Therapy

We now have fracture risk reduction evidence from 2 separate trials comparing oral bisphosphonates with osteoanabolic medications. These well controlled phase III trials of FDA-approved medications showed superior fracture risk reduction with teriparatide vs risedronate in the VERO trial, and romosozumab vs alendronate in the ARCH trial. In these head-to-head trials, incidence of vertebral fracture, time to first clinical fracture, and time to first nonvertebral fracture were significantly reduced with teriparatide and romosozumab when compared with oral risedronate or alendronate, respectively.

The key point of these trials is that osteoanabolic therapies reduce fracture risk in a shorter time period and provide statistically better fracture protection than do oral bisphosphonates. The populations targeted for treatment in both of the trials included high-risk and very-high-risk postmenopausal women. Risk categories for osteoporosis have been similarly defined in each of the following 2020 guideline updates: the American Association of Clinical Endocrinologists (AACE; detailed below), the Endocrine Society, and the International Osteoporosis Foundation. Each organization came to its stratification decision independently of the others.

With this relatively new information from the VERO and ARCH trials, it is now possible to treat patients with targeted therapy based on the updated risk stratifications: Patients who fall into either the high-risk or very-high-risk category can be started on the one of these osteoanabolic agents as first-line therapy. In western Connecticut, either rheumatologists or endocrinologists are prescribing these injectable anabolic medications; private practices often administer these medications in their own offices, while hospital-based practitioners often use their outpatient IV department to administer—or teach patients how to administer—these medications.

Prior authorization is key for patients to receive these medications. Our office employs a "buy and bill" system for acquiring them. However, this is a time-consuming process and is difficult for primary care practices to carry out. It is important to locate rheumatologists and endocrinologists in your own community who are administering these medications, as there are clear benefits to them. For many in the osteoporosis field, it is now prime time to use osteoanabolic therapy in high-risk or very-high-risk groups.

AACE 2020 Risk Stratification for Osteoporosis

High Risk

  • History of fragility fracture of hip/spine and T-score between –1.0 and –2.5
  • T-score between –1.0 and –2.5 and a Fracture Risk Assessment Tool (FRAX) 10-year probability of major osteoporotic fracture ≥20% or 10-year probability of hip fracture ≥3%

Very-high Risk

  • Fracture within the past 12 months, multiple fracture history
  • Fracture while on approved osteoporosis therapy OR while on drugs causing skeletal harm (ie, long-term glucocorticoids)
  • Very low T-score (< –3.0)
  • High risk of falls/history of falls with injury
  • FRAX estimates of: >30% for any major osteoporotic fracture, >4.5% for hip fracture
  • Camacho P, et al. American Association of Clinical Endocrinologists/American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis—2020 update. Endocrine Practice. 2020;26:1.
  • Kendler DL, et al. Effects of teriparatide and risedronate on new fractures in post-menopausal women with severe osteoporosis (VERO): a multicentre, double-blind, double-dummy, randomised controlled trial. Lancet. 2018;391:230.
  • Saag KG, et al. Romosozumab or alendronate for fracture prevention in women with osteoporosis. New Engl J Med. 2017;377:1417.

Filed under: Orthopedics, Rheumatology

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