Men's Osteoporosis Support Group
Study of 1.62% testosterone gel and compliance with osteoporosis medications
J Sex Med. 2011 Apr 14. doi: 10.1111/j.1743-6109.2011.02265.x. [Epub ahead of print]. Efficacy and Safety Study of 1.62% Testosterone Gel for the Treatment of Hypogonadal Men. Kaufman JM and others. PMID: 21492400. This study involves testing a new formulation of testosterone gel. It has increased viscosity, reduced volume when applied and improved skin permeation compared to other gels.
It was tested to check its safety and effectiveness on 234 men aged 18 to 80 years with low serum testosterone levels and compared to 40 placebo cases not getting any active therapy for a total of 182 days.
The gel was applied in one of five different total volumes: 1.25 g, 2.5 g, 3.75 g, and 5.0 g, or placebo gel, to the shoulder or stomach skin. If early results showed no effect, the dose was increased at 14, 28 and/or 42 days.
Results showed the percentage of subjects reaching average serum testosterone concentration in the normal range of 300-1000 ng/dL. There were significantly more men in that range (P <0.0001) from the group receiving the 1.62% gel compared to placebo. And it was safe and well tolerated.
The authors concluded, “In this study, treatment with 1.62% testosterone gel was safe and efficacious, resulting in an acceptable percentage of hypogonadal males achieving eugonadal [normal range] serum testosterone levels.”
Editor's comments. Hypogonadism can be the sole source of osteoporosis in men or can be a contributing factor. As such, serum testosterone levels need to be brought back into the normal range. This can be the only treatment needed to resolve the osteoporosis or in can be an adjunct along with other FDA-approved osteoporosis medications.
The approved testosterone treatments can involve injectable forms, patches, or gels. Being hypogonadal myself, I have used all three forms, starting first with injections, then trying the gel before finding the patch both effective and easy to use. The injections were painful and only lasted a couple of weeks, so I was happy to go to another method. The Androgel I tried had no effect. Here is an Update regarding Testim gel, which I have not tried. And the Androderm patch is what I'm using currently. My only problem with that is if I exercise strenuously in high heat and humidity the patch will sometimes fall off.
Here is another Update discussing a new twice-daily oral testosterone formulation and and injectable formula needed only every 10 weeks.
So the Kafuman study shows promise as another testosterone gel should be getting FDA approval, the 1.62% gel. And what is nice is that it will likely be in several formulations so you can find the concentration that is right for you.
The bottom line is that hypogonadal men have multiple options to restore their serum testosterone to normal levels. Talk to your care provider and find the one that works best for you.
Brief article discussions. Adherence to taking an FDA-approved osteoporosis medication is often poor, but the following study shows that it really helps to prevent fractures. See Lin TC and others study, PMID: 21525868. To highlight the fact that non-compliance is a problem, this study found only a 38% rate of compliance (medication possession ratio less than 80%) in people who had previous osteoporosis fractures. However, of those who were compliant, they had a 70% reduction in second fractures. The bottom line is that you are at much greater risk for a second fracture if you don't take your medications.
One method to improve compliance could be through the DOTS program as discussed in a recent NPR Radio Times podcast with Tina Rosenberg about her book “How Peer Pressure Can Change the World.” This program involves someone visiting the person needing to take the medication to assure they actually do. This has been shown to dramatically improve the compliance of those needing medications, and thus to improve health and control disease. Here is a discussion of the DOTS program as it was originally intended to treat tuberculosis.