2006
DOI: 10.2146/ajhp060100
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Prasterone

Abstract: FDA has granted orphan drug status for the prevention of loss of bone mineral density in SLE patients taking glucocorticoids. FDA is requesting additional Phase III trial data for the treatment of SLE and the prevention of loss of bone mineral density.

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Cited by 7 publications
(8 citation statements)
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“…It has been granted an orphan drug status by the FDA (prasterone) for preservation of bone mineral density in lupus patients receiving glucocorticoids. 33 …”
Section: Discussion Point 9: the Use Of Dhea And Testosterone Therapymentioning
confidence: 99%
See 1 more Smart Citation
“…It has been granted an orphan drug status by the FDA (prasterone) for preservation of bone mineral density in lupus patients receiving glucocorticoids. 33 …”
Section: Discussion Point 9: the Use Of Dhea And Testosterone Therapymentioning
confidence: 99%
“…33 Elevated endogenous DHEA sulfate levels are associated with an increased risk of breast cancer. 38 …”
Section: Discussion Point 9: the Use Of Dhea And Testosterone Therapymentioning
confidence: 99%
“…Other declared AAS included: 25R spirostan‐5A‐diol‐6‐one‐3‐one (three products, always in association with DHEA), methandrostenol (2), cyclostanozol (2), 3‐undecanodrol (1), prasterone (1), nandeconate (1), and oxantrione (1). None of these compounds could be identified as existing molecules, with the partial exception of 25R spirostan‐5A‐diol‐6‐one‐3‐one, which might stand for 5‐α, 25R 5‐hydroxy‐spirostan‐3,6‐dione (Dawidar et al, 1980), and of prasterone, which might indicate the proprietary name of a DHEA‐containing product (Kocis, 2006). Methandrostenol might stand for methandrostenolone; however, the content declared (230 mg/capsule) would be exceedingly high for this compound.…”
Section: Resultsmentioning
confidence: 99%
“…3‐undecanodrol (in some way resembling nandrolone decanoate), cyclostanozol (stanozolol), nandeconate (again, nandrolone decanoate), oxantrione (oxandrolone). Prasterone resembles the proprietary name of a DHEA‐containing medicinal (Kocis, 2006), another possible strategy to deceive purchasers. Another indirect evidence, in particular for AAS‐containing products sold as medicines, that they might not necessarily contain the compound and/or the amount declared comes from comparison of selling prices with those of corresponding medicines.…”
Section: Discussionmentioning
confidence: 99%
“…In this group, DHEA therapy has been shown to restore bone mineral density when used at doses of 100-200 mg/day, somewhat higher than the 50 mg/day used in most 'replacement' studies. 28 The US Food and Drug Administration has recently given DHEA 'orphan drug status' for the prevention of loss of bone mineral density in SLE, but has, at the same time, called for further studies into the long-term effects of DHEA.…”
Section: Bone Mineral Densitymentioning
confidence: 99%