Isnt Osta a SARM? Selective Androgen Receptor Modulator? I am by no means an expert in these but arre they safe for women?
I am by no means an expert either and hence why i suggested Miss Q research them and decide for herself whether she thinks they are safe...that said don't get caught on the "androgen" portion of its name...
GTx, Inc. (Nasdaq: GTXI), the Men's Health Biotech Company, today announced that ostarine, a first-in-class selective androgen receptor modulator (SARM), met its primary endpoint in a Phase II proof of concept double blind, randomized, placebo controlled clinical trial in 120 subjects (60 elderly men and 60 postmenopausal women). Without a prescribed diet or exercise regimen, all subjects treated with ostarine had a dose dependent increase in total lean body mass (muscle), with the 3 mg cohort achieving an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) after three months of treatment. Treatment with ostarine also resulted in a dose dependent improvement in functional performance measured by a stair climb test, with the 3 mg cohort achieving a clinically significant improvement in both speed (p=0.006) and power (p=0.005).
Ostarine continued to demonstrate a favorable safety profile, with no serious adverse events reported. Ostarine also exhibited tissue selectivity with beneficial effects on lean body mass and performance and with no apparent change in measurements for serum PSA (prostate), sebum production (skin and hair), or serum LH (pituitary) compared to placebo.
"These results are exciting," said William J. Evans, Ph.D., Professor of Geriatrics, Physiology, and Nutrition at the Donald W. Reynolds Institute of Aging of the University of Arkansas for Medical Sciences. "Not only was there a change in lean body mass in the clinically significant range, but a significant change in functional performance was also seen.
A clear anabolic effect with little to no unwanted androgenic effect was demonstrated, which should be the hallmark of a SARM."
The Phase II clinical trial evaluated four doses of ostarine (0.1 mg, 0.3 mg, 1 mg, and 3 mg) versus placebo for three months in 60 elderly men (average age 66 years) and 60 postmenopausal women (average age 63 years). The trial was conducted in five clinical sites in the United Kingdom and Germany.
A summary of the topline data is as follows:
Primary endpoint: total lean body mass (LBM) measured by dual energy x-ray absorptiometry (DEXA) at baseline compared to three months
-- Among all subjects (n=114), ostarine treatment resulted in a dose dependent increase in total lean body mass, with an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo (p<0.001) at the 3 mg dose.
-- Among females (n=56), ostarine treatment resulted in a dose dependent increase in LBM with the 3 mg dose having an increase of 1.7 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.02).
-- Among males (n=58), treatment with a 1 mg dose of ostarine resulted in a LBM increase of 0.7 kg compared to baseline and an increase of 1.2 kg compared to placebo (p=0.03), and treatment with a 3 mg dose of ostarine resulted in an increase of 1.0 kg compared to baseline and an increase of 1.4 kg compared to placebo (p=0.005).
GTx Announces That Ostarine Achieved Primary Endpoint Of Lean Body Mass And A Secondary Endpoint Of Improved Functional Performance
Clinical development (GTx, Inc.)
OstarineTM is an aryl propionamide SARM and the most advanced clinical candidate. OstarineTM demonstrated exciting data in an initial proof-of-concept Phase IIa clinical trial. GTx, Inc. reported in December 2006 the results of this clinical trial, which was a double blind, randomized, placebo-controlled trial in sixty elderly men and sixty postmenopausal women [Dalton, 2007a; Dalton, 2007b].
Without a prescribed diet or exercise regimen, all subjects treated with OstarineTM had a dose-dependent increase in total LBM, with the 3 mg/day cohort achieving an increase of 1.3 kg compared to baseline and 1.4 kg compared to placebo after 3 months of treatment. Treatment with OstarineTM also resulted in a dose-dependent improvement in functional performance measured by a stair climb test, with the 3 mg/day cohort achieving clinically significant improvement in speed and power. Interestingly, subjects treated with 3 mg/d of OstarineTM had on average an 11% decline in fasting blood glucose, a 17% reduction in insulin levels, and a 27% reduction in insulin resistance (homeostasis model assessment) as compared to baseline, suggesting that SARMs might have therapeutic potential in diabetics or people at risk for diabetes. Phase I clinical studies with OstarineTM showed that it was rapidly absorbed after oral administration with a half-life of about 1 day (unpublished data). An additional Phase II study in muscle wasting associated with cancer cachexia began in 2008 as an early objective of clinical development. OstarineTM also resulted in a dose-dependent decrease in LDL and HDL cholesterol levels, with the average LDL/HDL ratio for all doses remaining in the low cardiovascular risk catergory.
Selective androgen receptor modulators in preclinical and clinical development
Hope this helps Miss Q
