Phase 1
Completed N=31
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
Source: ClinicalTrials.gov NCT01101061 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 6; 4; 3; 6 Participants
Summary
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
6; 4; 3; 6; 2; 4 | — |
| PRIMARY Number of Participants Who Developed Anti-romosozumab Binding Antibodies |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Serum Calcium Levels |
2.34; 2.31; 2.33; 2.38; 2.28; 2.45 | — |
| PRIMARY Serum Intact Parathyroid Hormone (iPTH) Levels |
4.47; 4.24; 4.93; 3.63; 3.77; 2.73 | — |
| SECONDARY Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP) |
26.85; 59.23; 102.57; 196.37; 8.30; 164.44 | — |
| SECONDARY Maximum Percent Change From Baseline in Serum C-telopeptide (CTX) |
-12.64; -16.19; -35.92; -39.17; -25.46; -43.32 | — |
| SECONDARY Percent Change From Baseline in Sclerostin |
-3.78; 6639.01; 13749.61; 17028.81; -17.95; 14652.96 | — |
| SECONDARY Time to Maximum Observed Concentration of Romosozumab |
5.0; 5.0; 5.0; 5.0 | — |
| SECONDARY Maximum Observed Concentration of Romosozumab |
4.06; 17.1; 33.8; 18.6 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab |
64.0; 344; 804; 412 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab |
64.7; 347; 806; 421 | — |
| SECONDARY Apparent Clearance (CL/F) of Romosozumab |
18.6; 9.27; 6.98; 7.91 | — |
| SECONDARY Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab |
15.1; 16.2; 15.3 | — |
| SECONDARY Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab |
5.82; 6.31; 7.19; 6.81 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
- Body mass index ≤ 25 kg/m², inclusive at screening
- Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)
Exclusion Criteria
- Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5
- History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
- Diagnosed with any condition that will affect bone metabolism
Data sourced from ClinicalTrials.gov (NCT01101061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.