Contrary to current recommendations, preventive treatment for osteoporotic fractures should start earlier, including at a stage when bone loss after menopause is still moderate (osteopenia). Paradigm shift in sight.
Blessed be the time for generics: we can finally conduct independent studies that address real health issues and not studies subject to the financial diktats of industrialists or public authorities.
A independent study prevention of osteoporotic fractures in postmenopausal women goes against the official recommendations. It shows that the earlier administration of an anti-osteoporosis treatment in women at low risk of fracture, nevertheless reduces it by a third. It suffices to treat 15 women to avoid a fracture, a very low ratio and largely compatible with the economic constraints of health, especially when it is a question of an already generic treatment.
Finally a logical study in osteoporosis
The mostly Fragility fractures after menopause occur in women who still have little bone loss (densitometric osteopenia), as measured by bone densitometry. However, anti-osteoporotic treatments are currently indicated in cases of densitometric osteoporosis (i.e. those with a T score less than -2.5 ds in densitometry) and if possible after the occurrence of a first fracture of fragility.
Logic would dictate that if we really want to prevent osteoporotic fractures associated with menopause and aging, treatment should be initiated before the fracture stage, and therefore in women who have simple osteopenia of the bone.
This reality is all the more necessary because we currently only have anti-osteoporotic treatments which do not produce a lot of bone (anti-resorber type). These work all the better when the bone loss is limited and there is still a bone architecture to repair, that is to say most often at the stage of densitometric osteopenia.
An independent study on osteopenia
A study carried out by the New Zealand state wanted to verify the effectiveness of an anti-osteoporosis treatment in this type of woman. She tested the efficacy of a generic bisphosphonate, zoledronate, administered intravenously once every 18 months (which has the additional advantage of eliminating a bias linked to non-compliance with treatment).
Two thousand women over 65 with densitometric osteopenia of the femur, that is to say a score between -1.0 and -2.5 ds, were drawn at random between 2 management strategies: either a minimum adjustment of the vitamin-calcium intake with physiological saline infusion, or the same hygieno-dietetic measures, but associated with an infusion every 18 months of 5 mg of zoledronate by the intravenous route.
A reduction of at least a third of fractures
On inclusion, these women were on average 71 years old, the Tscore was -1.6 ds at the femur and the 10-year risk of major fractures was 2.3%.
Despite this low theoretical risk, 190 fractures were observed in the standard group against 122 in the treated group, i.e. a 34% reduction in the relative risk of major fractures after 6 years. The efficacy remains preserved even if we exclude women who have the lowest bone densities (in fact those who have densitometric osteoporosis with a T score <-2.5).
This reduction breaks down into a 34% reduction in the risk of fragility fractures other than vertebral (and in particular the hip), a 27% reduction in the risk of symptomatic fractures (painful and disabling) and a 55% reduction in the risk of vertebral fractures ( with less loss of size). All of these results are significant.
Validation of efficacy in the best indication
This study is particularly interesting because it validates the efficacy of an anti-osteoporosis treatment in women who are currently not concerned by the treatments in the recommendations, as in the marketing authorizations for these drugs.
In addition, treatment with IV zoledronate is effective even when administered every 18 months in this study, whereas in its current authorization, in osteoporosis, the administration time is 12 months. It therefore seems necessary to re-discuss the frequency of administration of this molecule to change to an 18-month interval between infusions.
This study therefore validates the clinical observations of many clinical physicians who recognized this more prolonged efficacy than that of the MA, especially as other studies show that the effect on bone remodeling can last for up to 5 years.
A beautiful study over 6 years
Hats off to the researchers who carried out this study and show that it is possible to carry out studies of very good quality for 6 years (96% and 97% of patients still followed in the study at its end!).
They also provided other interesting information by analyzing all the side effects. These are consistent with what can be seen in other studies with bisphosphonates and zoledronate, however, with a lower frequency of cancer (significant) and a tendency for a lower frequency of vascular accidents. They observed 3 sudden deaths in the zoledronate group instead of one under placebo: given the rarity of the event, this last figure may be linked to a statistical anomaly.
On the other hand, for the other differences, the previous studies, without always being significant, were already in favor of a beneficial effect of certain bisphosphonates on the occurrence of cancers and cardiovascular events and the reduction in mortality. These 2 sudden deaths in addition can be linked to chance but must remind us to check that the vitamin-calcium metabolism is balanced before carrying out the first infusion (by a systematic phosphocalcic balance).
In the end, even if you want to prevent fractures, you might as well use these anti-osteoporotic treatments currently available (anti-resorbers) before the onset of the first fragility fracture and not be satisfied with preventing the fracture from recurring. When effective treatment is available, the occurrence of a single fragility fracture is medically unsuccessful.
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