A First-in-Human Study Evaluating AMG 785 (Romosozumab) in Healthy Men and Postmenopausal Women
74 healthy males; postmenopausal females, ages 45–59 years
Postmenopausal women: one dose of romosozumab: 0.1, 0.3, 1, 3, 5, or 10 mg/kg SC or 1 or 5 mg/kg IV or placebo SC or IV Men: one dose of romosozumab: 1 or 5 mg/kg SC or IV or placebo
Number of subjects (%) experiencing clinically significant changes in vital signs, physical exam, laboratory tests, and ECGs; developing anti-AMG 785 antibodies; reporting treatment-emergent adverse events up to 85 days after drug administration
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785
48 healthy males and postmenopausal females (osteopenia), ages 45–80 years
1 mg/kg SC every 2 weeks × 6 doses; romosozumab or placebo 3 mg/kg every 4 weeks × 3 doses; romosozumab or placebo 2 mg/kg every 2 weeks × 6 doses; romosozumab or placebo 2 mg/kg every 4 weeks × 3 doses
Number of subjects (%) with clinically significant changes in vital signs, physical exam, laboratory tests, and ECGs; developing anti-AMG 785 antibodies; reporting treatment-emergent adverse events up to 169 days after initial drug administration
A First-in-Human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women
69 healthy males and postmenopausal females (osteopenia) ages 45–65 years
Postmenopausal women: one dose AMG 167 or placebo 21 mg, 70, 210, 350, or 700 mg SC or 70 mg or 350 mg IV Men: 70 mg or 350 mg SC or IV
Number of subjects (%) experiencing clinically significant changes in safety laboratory tests, physical examinations, vital signs, or ECGs; developing anti-AMG 167 antibodies; reporting treatment-emergent adverse events up to 85 days after drug administration
A Multiple-Dose Study of LY2541546 (Eli Lilly) in Healthy Postmenopausal Women
59 healthy postmenopausal females, ages 45–80 years
180 mg LY2541546 SC Q4W for 8 weeks or placebo at weeks 2 and 6 270 mg LY2541546 SC Q2W or Q4W for 8 weeks or placebo at weeks 2 and 6 540 mg IV Q4W for 8 weeks or placebo IV at weeks 2 and 6 750 mg LY2541546 IV Q2W for 8 weeks Placebo comparator IV or SC Q2W for 8 weeks
Number of subjects with 1+ SAE up to 141 days after drug administration
A Study of LY2541546 in Healthy Postmenopausal Women
60 healthy postmenopausal females, ages 45–70 years
Single dose of 7.5 mg; 25 mg; 75 mg; 225 mg; 750 mg LY2541546 IV; single dose of 150 mg LY2541546 SC; single dose of placebo administered IV or SC; single dose of 225 mg or 750 mg LY2541546 IV, OL
Number of subjects with 1+ SAE up to 85 days after drug administration
A Single-Dose Study Evaluating AMG 785 in Healthy Postmenopausal Japanese Women
31 Japanese postmenopausal females, ages 45–70 years
Postmenopausal Japanese women: 1 mg/kg, 3 mg/kg, or 5 mg/kg AMG 785 or placebo Postmenopausal non-Japanese women: 3 mg/kg AMG 785 or placebo
Number of subjects (%) experiencing clinically significant changes in vital signs, physical exam, laboratory tests, and ECGs; developing anti-AMG 785 antibodies; reporting treatment-emergent adverse events up to 85 days after drug administration
Ascending-Multiple-Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density
74 healthy men and postmenopausal women (low BMD), ages 45–75
Postmenopausal women: AMG 167 or placebo in one of 3 fixed doses SC Healthy men: AMG 167 or placebo in one of 2 fixed doses SC (doses not specified)
Number of subjects (%) experiencing clinically significant changes in vital signs, physical exam, laboratory tests, and ECGs; developing anti-AMG 785 antibodies; reporting treatment-emergent adverse events up to 336 days after drug administration
A Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
402 skeletally mature adults with a unilateral closed or Gustilo type I or II open tibial fracture and fracture fixation with intramedullary nailing, ages 18–85 years
Two, three, or four doses of AMG 785 70 mg, 140 mg, or 210 mg or four doses of placebo
Time to radiographic healing for AMG 785 versus placebo groups over 24 weeks
Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 (Novartis) in Adults with Hypophosphatasia
9 healthy male and female subjects, ages 18–70 years
Dose escalation (doses not specified)
Number (%) of subjects experiencing adverse events or SAE; change from baseline in primary serological bone biomarkers up to 141 days after drug administration
A Study of LY2541546 in Women with Low Bone Mineral Density
153 postmenopausal women (low BMB), ages 45–85 years
LY2541546 SC every 4 weeks with placebo given every alternate 2 weeks (patient will receive an injection every 2 weeks) for 52 weeks 180 mg or 270 mg LY2541546 SC or placebo given every 2 weeks for 52 weeks LY2541546 SC every 12 weeks or placebo every 2 weeks when LY2541546 is not administered for 52 weeks
Change from baseline to 52-week endpoint in lumbar spine BMD
Safety and Efficacy of Multiple-Dosing Regimens of BPS804 in Postmenopausal Women with Low Bone Mineral Density
44 postmenopausal women (low BMD), ages 45–85 years
BPS804 or placebo at dosing frequency 1, 2, or 3 (not specified)
Change from baseline in BMD in lumbar spine to month 9 in bone mineral density at the lumbar spine for the individual BPS804 groups and pooled placebo arms after 9 months; number (%) of subjects experiencing adverse events or SAE
Study of Romosozumab (AMG 785) Administered to Healthy Subjects and Subjects with Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Haemodialysis
24 males and females, age ≥ 50 years (healthy, stage 4 renal impairment; end-stage renal disease)
Single-dose romosozumab SC (not specified)
Incidence of treatment-emergent adverse events; results of safety laboratory tests, vital sign measurements or ECG measurements; development of anti-romosozumab antibodies
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women with Osteoporosis
4094 postmenopausal women with osteoporosis at high risk for fracture: hip BMD -score ≤ −2.5 SD and a vertebral fracture or hip BMD -score ≤ −2.0 SD and a recent hip fracture or two vertebral fractures, ages 55–90 years
Romosozumab SC injections and placebo alendronate (oral) for 12 months followed by OL alendronate (oral) for at least another 12 months (until end of study) Oral alendronate and placebo AMG 785 subcutaneous injections for 12 months, followed by open-label alendronate (oral) for at least another 12 months (until end of study)
Incidence of clinical fracture or new vertebral fracture at 24 months after drug administration
May 2017
BMD: bone mineral density; ECG: electrocardiogram; IV: intravenously; OL: open label; SAE: serious adverse events; SC: subcutaneously; QW: weekly; Q2W: once every 2 weeks; Q4W: once every four weeks; QD: daily; QM: every month.