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Growth hormone prevents fractures? News release is silent on other factors that likely contributed to study benefit

Growth hormone reduces risk of osteoporosis fractures in older women

Our Review Summary

osteoporosis word written by 3d handThis release focuses on a study that reports long-term benefits in regard to bone density and reduced risk of bone fractures for women with osteoporosis who take growth hormone. However, the release does not make sufficiently clear that this was a small-scale study nor does it mention any risks or side effects associated with the use of growth hormone. Perhaps more important, this was essentially an observational follow-up study to the original trial, and there were a number of factors discussed below in our review that could have confounded or biased the results. We think it’s inappropriate to conclude, as the headline does, that “Growth hormone reduces risk of osteoporosis fractures” without at least some mention of these limitations.

 

Why This Matters

Osteoporosis affects around 16 percent of U.S. women over the age of 50 and can cause back pain and increase the risk of bone fractures — including hip and other fractures with significant consequences for health and well-being. That means millions of people are affected and, with an aging population, that number is likely to go up. Given the large number of people living with osteoporosis, it makes sense to highlight research that has the potential to mitigate the health risks associated with the condition. But it’s also important to note the limitations of that research.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release does not mention cost at all, possibly because the study was conducted in Sweden, which has a taxpayer-funded public health system. However, in the U.S., growth hormone treatments can cost hundreds of dollars per month — and it’s not clear if that would be covered by insurance for treating osteoporosis. This high cost is certainly worth mentioning.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The release notes that the rate of bone fractures among study participants declined by 50 percent over the 10-year course of the study and provides an absolute measure of that benefit: 56 percent of participants had experienced a bone fracture before the study, and 28 percent had a bone fracture over the course of the study. We’ll give credit for the quantification, however it must be noted that this before and after comparison is seriously limited in what it can tell us about the benefits of growth hormone treatment — something addressed below under the “Evidence” criterion.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release doesn’t mention potential harms at all. Given the wide range of potential side effects from growth hormone use — from headache and joint pain to weight gain and weakness — this is a significant oversight.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release does a fair job of describing the study design. It was a three-year, randomized, double-blind trial of 80 postmenopausal women with osteoporosis, with a seven-year follow-up period. The study also included a control group of 120 women who did not have osteoporosis — at least when the study began. However, the release does not sufficiently highlight the limitations of the study, which are significant. It’s problematic to attribute the benefits observed 10 years after the study began (and 7 years after stopping treatment) entirely to growth hormone therapy as this release does. About a quarter of the women in the study started taking fracture-preventing bisphosphonate drugs during the follow-up period. Is it possible that those drugs had an impact on the fracture rates seen in the study? Without a true placebo control group (patients stopped receiving placebos 18 months into the study and started receiving growth hormone), it’s impossible to differentiate the effects of the growth hormones, the bisphosphonates, or possibly other factors (e.g. fall prevention measures, vitamin D supplements) that were introduced during the study and which may have contributed to the before/after difference in fracture rates.

Another important limitation mentioned by the study authors in their paper (but not in the release) is the small sample size. Only 27 women received the high dose of growth hormone, only 28 received the low dose, and 25 received the placebo. While a study of 80 people can show promise, it’s worth mentioning that this study would need to be replicated on a larger scale in order to determine whether the findings hold up and can be extrapolated to a larger population.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release provide no information on who funded the study. The research was funded by the University of Gothenburg as well as a variety of public grants. The independent nature of the research was worth mentioning.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release does not mention other osteoporosis treatment options — such as bisphosphonates, fall prevention interventions, etc. — at all, making it impossible for readers to determine how the growth hormone therapy performed relative to other courses of action.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Many readers may know that growth hormones are available and already used for the treatment of short stature in children. But the release doesn’t establish this for those who might not know. Are these hormones prescription-only? Over the counter? Was it a new formulation developed for use in the study? It’s impossible to tell.

Does the news release establish the true novelty of the approach?

Satisfactory

The release establishes what’s new about the study, calling it the largest and longest of any study of growth hormone for osteoporosis to date. However, it would have been useful to inform readers about the long history of research in this area. The release does not mention any previous work, making it difficult for anyone (and impossible for non-experts) to place this new work in context with earlier research — whether that work is 40 years old or more recent.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release is careful in its use of language. Any problems with the release revolve around what was left out, rather than on the language of the release.

Total Score: 4 of 10 Satisfactory

Comments (1)

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Michal

October 31, 2015 at 4:44 am

Extra growth hormones will only choose somewhere else from the body functions. Probably in a few areas of the particular bone or perhaps muscle and also it’ll mount up awkwardly.

Reply