Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

reading method. Responders (patients with no relevant progression) were defined as those with a JSW loss between baseline and End, lower than 0.1 mm (JSN >-0.1 mm), or 0.2 mm (JSN >-0.2 mm) or 0.3 mm (JSN>-0.3 mm). Patients who withdrew from the study were counted as non-responder patients. SrRan 1g and SrRan 2g treatment groups were compared to placebo in the FAS using a chi 2 test. Results: The ITT set included 1371 (82%) patients. Age was 63AE7 years, BMI was 30AE5 kg/m2, JSW was 3.5AE0.8 mm. 61% were KL II. 69% were female. A statistically significant greater proportion of patients in both SrRan 1 g and SrRan 2 g groups were considered as responders (i.e. preserved from a radiological progression) as compared to placebo, when defined by a JSN >-0.3 mm threshold (40.5% and 44.1% vs. 32.8% of responders respectively, p¼0.006 and p¼0.003). In other words, the proportion of responders compared to placebo increased by 24% and 34% in the SrRan 1g and 2g groups respectively, using a JSN >-0.3 mm for responding definition, with a number of patients needed to be treated (NNT) of 13 and 9 respectively. Similar differences between groups were observed for responders at additional JSN cutoffs (i.e. JSN >-0.1 mm or JSN >-0.2 mm):

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E2, 0.17 mg/kg body weight/day); and OVX with BHH10 in graded doses (250, 500, or 750 mg/kg/day). Daily oral administration of BHH10, ALN or E2 started on week 2 after OVX and continued for 12 weeks. Body and uterus weight, serum biochemical bone turnover markers, bone mineral density (BMD), and microarchitectural parameters were assessed. Results: BHH10 inhibited OVX-induced body weight gain, uterus atrophy, and significantly decreased levels of the bone formation markers serum alkaline phosphatase (ALP) and osteocalcin (OCN), and the bone resorption parameter C-telopeptide type 1 collagen (CTX). BHH10 also notably enhanced BMD and bone microstructure in both total femur and femoral neck measurements compared to OVX rats. Conclusions: These results suggested that BHH10 administration improved biochemical markers of bone metabolism, bone biomechanical quality, and bone structural integrity in OVX rats. The potent anti-osteoporosis effect of BHH10 might be mediated by its action of stimulating bone formation and regulating bone resorption with no significant toxicity.