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Bone-Building Meds Battle Osteoporosis: These drugs stimulate new bone growth, making them powerful weapons against advanced osteoporosis.

As the population ages, osteoporosis is a growing problem in both women and men. Loss of bone mineral density (BMD) increases the risk of fractures, which can lead to disability, pain, and reduced quality of life. Hip fractures are particularly dangerous. They're linked to a higher risk of death, particularly in men, and a higher likelihood of losing the ability to live independently in both sexes. But two new drugs may change the osteoporosis landscape by helping the body regrow lost bone, according to a review published in the February issue of the Journal of Molecular Biology.

Traditional Care. Most people with osteoporosis take antiresorptives, drugs that slow the breakdown of bone to increase BMD. These medications are clearly beneficial and can help reduce the risk of fractures, but when people have more advanced osteoporosis, they may not be enough.

Enter the anabolics, a class of drugs that directly stimulate new bone growth. The first anabolic drug to be approved by the FDA for osteoporosis, teriparatide (Forteo, Lilly), increases BMD while lowering the risk of fractures. While effective, teriparatide is significantly more expensive than antiresorptive osteoporosis drugs, partially because there hasn't been competition, the review authors noted--until now.

Abaloparatide (Tymlos, Radius Health).

This FDA-approved parathyroid hormone-related protein analog performed impressively in the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) study, which compared it with both teriparatide and placebo in postmenopausal women who had already experienced a fracture. Compared with placebo, abaloparatide reduced the rate of new vertebral fractures by a whopping 86 percent over 18 months. Furthermore, it led to greater increases in BMD than both placebo and teriparatide.

Another study, ACTIVExtend, evaluated the effects of using a course of abaloparatide followed by a course of an antiresorptive called alendronate. At the six-month mark, patients who took both had significantly higher BMD than patients who took a placebo before taking the antiresorptive. After 43 months of treatment, the active study group had an 84 percent relative risk reduction in new vertebral fractures compared with the placebo group. Radius Health is conducting a 12-month study to assess the effectiveness of abaloparatide in 225 men.

Potential side effects include elevated calcium levels in the blood, gastrointestinal complaints, injection-site reactions, dizziness, and muscle pain. Both teriparatide and abaloparatide increased the risk of bone cancer in laboratory rats, but it is not clear if humans share the same risk.

Romosozumab (Evenity, Amgen). in the Fracture Study in Postmenopausal Women with Osteoporosis (FRAME), 7,180 postmenopausal women with osteoporosis received monthly injections of either romosozumab or placebo for one year. Both groups were then given the antiresorptive drug denosumab every six months for another year. In the first 12 months, there was a 73 percent decrease in the risk of new vertebral fractures and a 36 percent lower risk of clinical fractures in the romosozumab group. The FRAME authors concluded that romosozumab accomplished in two years what it would take seven years of denosumab to attain. A smaller study looked specifically at 225 men and reported that 12 months of romosozumab increased BMD in the spine and hip.

The FDA's Bone, Reproductive, and Urologic Drugs Advisory Committee voted 18-1 in favor of approving this monoclonal antibody in January, but several members were concerned about its risk profile. In clinical trials, the drug was linked to a 40 percent higher risk of major cardiovascular events, particularly heart attack and stroke. Clinical trials do not show an increased risk of bone cancer in laboratory rats.

The Journal of Molecular Biology review authors pointed out that studies consistently show that while anabolic treatments help grow new bone, they must be followed up with an antiresorptive medication to maintain and stabilize those improvements.

THOMAS F. KOINIS, MD, MSE

Family Medicine Doctor, Duke Primary Care, Oxford

Exciting New Options

"These two new anabolic, or bone-forming, medications are exciting additions in caring for those with osteoporosis. In primary care, treatment often begins and ends with calcium, vitamin D, and antiresorptive drugs like bisphosphonates and occasionally denosumab. Primary care providers have been uncomfortable in the past with initiating anabolic therapy due to issues like medication cost, daily injections, and simply being unfamiliar with how and when to use anabolic therapy. The marked increases to bone density shown by romosozumab and abaloparatide, particularly when followed by the use of a bisphosphonate, will be of special benefit to those with severe osteoporosis."
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Title Annotation:JOINTS & BONES
Author:Koinis, Thomas F.
Publication:Duke Medicine Health News
Date:May 1, 2019
Words:728
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