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Young People Get Osteoporosis Too 

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Natural Progesterone

There has been much interest in the effects of natural progesterone cream after observational data from the USA suggested it could prevent bone-loss in post-menopausal women and stimulate bone formation. We have been concerned for some years that many women are using these creams to prevent or treat osteoporosis without good supporting evidence that they are effective.

In this study, rubbing progesterone cream into the skin at these doses was unable to influence bone-loss significantly. Other results from the study suggested a trend that progesterone cream may be helpful in improving hot flushes and sweats in some women, compared to the placebo, although this was not as effective as HRT.

This is now the second placebo-controlled study to show that progesterone cream, used as recommended by the standard instructions, is not effective in preventing bone-loss in post-menopausal women. It therefore should not be considered a therapy for the prevention or treatment of osteoporosis.

Research finds progesterone creams do not halt bone loss

During the first year of the study at the Southampton Osteoporosis Research Unit into natural progesterone creams post-menopausal women were picked at random to use either a quarter of a teaspoon of the progesterone cream twice a day (40 mg progesterone) or an identical looking placebo cream. In the second year the progesterone cream group used half a teaspoon twice daily while the placebo group started to use a quarter of a teaspoon of the active cream twice a day. This second group was also given a comprehensive vitamin and mineral supplement.

For comparison, there was also a separate group of 14 women allocated to take hormone replacement therapy (HRT) using a skin patch, who underwent the same procedures as the cream groups. All the women were encouraged to eat healthy diets high in dairy calcium, fruit and vegetables and to follow the general lifestyle advice recommended by the NOS.

At the end of the first year, DXA scans of the lumbar spine showed that both groups using the active and placebo creams showed a similar loss in bone density, compared to the women using the HRT patch who showed an increase in their BMD.At the end of the second year, bone loss in the lumbar spine had continued in both the active cream groups, compared to a further increase in BMD for the women on HRT.

Measurements of bone-turnover markers showed no change in the progesterone groups compared to a suppression of turnover in the HRT group, further confirming the BMD findings. Other results from the study suggest a trend that progesterone cream may be helpful in improving hot flushes and sweats in some women, compared to placebo, although this trend was not as strong as shown with HRT.

Source:   National Osteoporosis Society Online located at http://www.nos.org.uk/researchupdate.asp


Does natural progesterone cream build bone?

One of progesterone cream's strongest proponents, Dr. John Lee, claims that progesterone cream actually reverses osteoporosis. However, he has published only one study in a medical journal. Although he reports that the women who used progesterone cream had increased bone density, he doesn't indicate whether they were also taking estrogen -- which has been proven to increase bone density. In other words, it's likely that the positive effect was due to estrogen, not progesterone cream. A few randomized studies have been conducted and none have found that progesterone cream increases bone density.7,8

The nature of natural progesterone creams

The creams are formulated from a vehicle -- a "base" of a fatty or oily substance -- and the active agent -- in this case, micronized natural progesterone. Micronized natural progesterone is extracted from diascorea, a variety of wild yam, and as such is considered a supplement rather than a drug and therefore does not require FDA approval. The creams are produced by compounding pharmacies, which make their own prescriptions rather than dispense products manufactured by drug companies. As a result, the creams aren't standardized, and there is no guarantee of the amount of progesterone in a cream. Nor is there much information about a cream's effectiveness, because the pharmacies aren't required to conduct clinical trials to test the product.
source:  Susan Love MD--The Website for  Women                                                                     

 Susan Love MD-Frequently Asked Questions-Natural progesterone cream

 


from Medscape Ob/Gyn & Women's Health
Natural Progesterone for Osteoporosis Prevention  

http://www.medscape.com/viewarticle/448859

Question
Is there a role for natural progesterone in osteoporosis prevention?
Response from Ego Seeman, MD, PhD
Professor, The University of Melbourne, Melbourne, Victoria, United Kingdom
 
No. The questions of why treat, whom to treat, and what drug to choose are fundamental. Why treat is straightforward. The purpose of treatment is to prevent the morbidity and mortality associated with fractures. Whom and when to treat is complex, and I will not deal with this here. The final question is drug choice, and this is the subject of your question. The answer is easy if we stick to the rules of evidence-based medical research, which provide clarity, but is complex if we break these rules. In terms of osteoporosis prevention, the rules are that drugs must be shown to reduce the risk of fracture in properly designed, executed, presented, and interpreted clinical trials. If this is not done, the drug may well be efficacious, but the evidence is not there one way or another, so the decision of whether to prescribe the drug will be according to feeling-based medicine or opinion-based medicine but not evidence-based medicine.

What are the rules of engagement? Inferences at the end of papers are always made by authors, but the validity of the inference cannot be deduced unless the rules are followed and the data are presented transparently.

The studies must be double-blind and placebo-controlled; they must involve large sample sizes and have few drop-outs; the end points should be numbers of persons with fracture, not numbers of fractures. The primary end points must be predefined and analysis carried out by intention to treat, not post hoc -- ie , the data are examined until something with statistical significance (P < .05) is squeezed out of the data and presented as if it was planned before the study was done. Finally, and perhaps most important, is reproducibility and consistency; the studies should be done by different investigators in different parts of the world and the same result observed. Not following these rules fosters confusion. Most studies don't fulfill all of these criteria, but the best studies follow most. The best studies we have to date are those of alendronate, risedronate, raloxifene, parathyroid hormone, and, more recently, strontium ranelate (the latter results have been presented but are unpublished at this time). The quality of the data for other drugs such as calcitonin, etidronate, menopausal hormone therapy, vitamin D metabolites, and calcium is not as compelling so that inferences are much more difficult to make -- they are made to be sure, but the rules of engagement are incompletely satisfied.

So, that's why the answer to your question is no. I have no idea whether natural progesterone reduces the risk of fracture -- there are no studies to answer this question. So, should you use the drug? In my opinion, a resounding NO.

 

 progesterone cream fails to stop bone disease

A hormone cream used by women to prevent the bone disease osteoporosis has been shown to be ineffective in tests.  Researchers carried out a year-long study into natural progesterone cream, which observational studies had previously shown improved bone health after the menopause.

Results of the study were presented to the National Osteoporosis Society (NOS) annual conference in Bath, the leading UK conference on the condition, where bones crumble and fracture easily.  The lack of estrogen women suffer after the menopause means they are more at risk of losing bone density and developing osteoporosis.

Women have chosen the cream as a natural alternative to hormone replacement therapy (HRT). The Osteoporosis Research Unit at Southampton University carried out a randomised trial to compare HRT, the progesterone cream and a placebo version.  Only the group taking HRT saw their bone density increase.  Though progesterone creams are not available over the counter in the UK, women can still buy them in European countries or the US, or on the Internet.

Informed choice

Fifty-three healthy women aged between 52 and 65 took part in the study.  Twenty-one were given a quarter teaspoon of progesterone cream, and twenty-one the same amount of a placebo cream, to rub into their skin twice a day.  The remainder were given an HRT patch.  Bone density at the spine and hip was measured, and blood and urine levels checked to monitor the cream's effects.  Bone density in the HRT group increased by about 5%, while women using both the progesterone cream and the placebo lost around 2.5%.

Professor Cyrus Cooper, director of the osteoporosis service at Southampton University told BBC News Online the research had shown "unequivocally" that the creams did not work.

He said: "These data suggest that natural progesterone cream at these doses do not prevent post-menopausal bone loss and cannot be viewed as an alternative to HRT for this purpose."

Professor Cooper added there was no indication the creams did any harm, and there were some indications they could be beneficial in terms of reducing severe menopausal symptoms such as hot flushes and night sweats.

Alternative treatments

Jackie Parrington, a nurse manager with the NOS, said: "The NOS helpline nurses take numerous calls from women interested in natural progesterone cream and wanting to know if it is going to protect their bones.  "This research will help women make a more informed choice about the treatment."

Dr Val Godfrey of the Amarant Trust, which offers women advice on the menopause and HRT, told BBC News Online: "I'm not at all surprised by these results."  She said previous work done by the trust had also indicated the creams failed to prevent a loss of bone density.

Dr Godfrey said many women did not want to take HRT, and went for the creams as the 'natural' option, even though doctors could prescribe other non-hormonal treatments.  "Hopefully, these findings will encourage women to ask questions a bit more," she said.

 
 

Young People Get Osteoporosis Too Organization
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Revised: 03/11/08.