Reviewed by Michael Gill, B. Sc.
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Most Recent Tymlos Clinical Trials

What Are Tymlos Clinical Trials?

Tymlos (abaloparatide) is a prescribed, anabolic medicine that is a synthetic form of parathyroid hormone that exists naturally in the body. It’s used for the treatment of postmenopausal women with osteoporosis who are at a high risk of bone fractures. It increases bone mineral density and bone strength, which may prevent fractures.

A patient with osteoporosis may receive denosumab, estrogens, calcitonin, or other drugs that reduce bone resorption and therefore prevent further bone loss. Traditionally, patients have been treated with antiresorptive drugs (biphosphonates, denosumab, estrogens, calcitonin) that suppress bone resorption by osteoclasts. Tymlos is now available to improve bone quality and bone microarchitecture.

Why Is Tymlos Being Studied In Clinical Trials?

The National Osteoporosis Foundation estimates that approximately 10 million Americans have osteoporosis, with another 44 million suffering from low bone density. A systemic disease, osteoporosis, results in a decrease in bone mass over time, decreased bone strength, and an increased risk for fractures. In women who are at high risk for bone fractures due to osteoporosis, Tymlos was approved by the Federal Drug Administration (FDA) as studies have shown that it decreases the chance of having a fracture of the spine and other bones. Specifically, Tymlos is most beneficial for treating women who have reached the age of menopause.

How Does Tymlos Treatment Work?

Once injected subcutaneously, Tymlos (abaloparatide) activates the PTH1 receptor. It stimulates the cAMP signaling pathway in target cells in humans. Abaloparatide had anabolic effects on bone mass and bone mineral content (BMC) as measured by bone mineral density (BMD) and BMC, respectively. These increases in bone strength were observed at vertebral and nonvertebral sites.

What are some of the breakthrough clinical trials involving Tymlos?

2017: Tymlos clinical trials conducted by Radius Health (a global biopharmaceutical company) examined the benefits of Tymlos. All patients underwent an 18-month treatment programme in which they received either Tymlos or placebo injections under the skin of their bellies daily. Neither patients nor medical professionals knew which treatment they were receiving until after the trial concluded.

The magnitude of improvement in the outcome was determined by comparing the number of new spinal fractures in patients that received Tymlos to those who received a placebo during the 18-month study. A different estimate of the improvement was derived by comparing the number of new bone fractures in patients that had previously received Tymlos with those that had previously received a placebo with alendronate and calcium in addition to vitamin D supplements for six months.

The study found that postmenopausal women who have osteoporosis may benefit from Tymlos, but the drug must still be evaluated against other osteoporosis therapies.

This was significant because the women taking Tymlos had an 86% lower risk of spinal fractures, a 43% lower risk of non-spinal fractures, and increased bone mineral density in the spine and hip, versus those on placebo. These results play a part in improving the overall quality of life.

Who Are The Key Opinion Leaders On Tymlos Clinical Trial Research?

Bruce Mitlak, M.D.Chief Medical Officer

Dr. Bruce Mitlak has served as Chief Medical Officer since December 2020 and Head of Discovery Science since August 2020. Previously, he served as Vice President, Clinical Development for abaloparatide since joining Radius in 2016.

About The Author

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

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