A new therapeutic approach substantially improves bone mineral density, to levels higher than those observed so far, and paves the way for effective treatment for people who suffer from osteoporosis and are at high risk of fragility fractures.
- This is shown by a study published in Lancet Diabetes & Endocrinology and conducted by a team at Harvard Medical School in Boston, combining a drug that stimulates bone tissue growth (teriparatide), used at a high dose, and one that inhibits bone resorption (denosumab): the result was a significant increase in hip and spine bone density, resulting in increased bone strength.
There were some adverse events, such as joint pain, fatigue, and nausea, but these appear to be outweighed by the benefits provided by the therapy, according to the authors.
The study supports recent Endocrine Society guidelines that recommend stratifying patients by fracture risk to determine the most appropriate therapy. “These results point to the possibility of improving treatment for people with osteoporosis at high risk of fracture and personalizing the approach, which is basically the same for everyone today,” said columnist Sundeep Khosla, an expert at the Mayo Clinic in Rochester, Minnesota.
Cooling hopes for widespread application of the new method, however, are the extremely high costs.
Based on current drug price estimates, a 15-month regimen could cost as much as $76,000 (just under 70,000 euros), and, according to Khosla, it is virtually impossible for U.S. physicians to obtain insurance company approval for combination osteoporosis therapy. In Italy, with a completely different health care system, the burden would be borne by the National Health Service and, given the increasing prevalence of osteoporosis, appears difficult to sustain. However, there have already been many examples where the prices of certain brand-name drugs have rapidly collapsed over time as demand has increased or due to patents expiring, paving the way for the production and distribution of the much cheaper equivalent drugs.
Source: Tsai JN, Lee H, et al. Combination denosumab and high dose teriparatide for postmenopausal osteoporosis (DATA-HD): a randomized, controlled phase 4 trial. Lancet Diabetes Endocrinol. 2019 Aug 22.