Phase 1
Completed N=48
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Romosozumab (AMG 785)
Postmenopausal · osteopenia
Source: ClinicalTrials.gov NCT01825785 ↗
Enrolled (actual)
48
Serious AEs
4.2%
Results posted
Jul 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 10; 6; 6; 6 Participants
Summary
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
10; 6; 6; 6; 5; 5 | — |
| PRIMARY Number of Participants Who Developed Antibodies to Romosozumab |
0; 2; 2; 2; 3; 1 | — |
| SECONDARY Time to Maximum Observed Concentration (Tmax) of Romosozumab |
3.0; 3.0; 4.5; 3.0; 3.0; 5.0 | — |
| SECONDARY Maximum Observed Concentration (Cmax) of Romosozumab |
6.80; 15.7; 14.8; 24.5; 8.06; 27.7 | — |
| SECONDARY Area Under the Concentration-time Curve for the Dosing Interval (AUC0-tau) for Romosozumab |
65.5; 202; 152; 340; 71.3; 434 | — |
| SECONDARY Half-life Associated With the Terminal Phase of Elimination (T1/2) for Romosozumab |
7.02; 6.51; 9.32; 6.84; 6.77; 6.07 | — |
| SECONDARY Accumulation Ratio (AR) for Romosozumab |
2.15; 1.17; 2.35; 1.35; 1.90; 1.26 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Total Spine |
-0.046; 2.161; 0.541; -0.495; -0.257; 2.662 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Total Hip |
-0.552; 0.528; -0.768; 0.112; -0.318; 1.244 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Femoral Hip |
-0.394; 0.300; -2.172; -0.811; -0.473; 0.471 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Distal One-third Radius |
1.676; -0.220; -0.900; -2.052; -2.968; -0.435 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density at the Total Wrist |
0.135; -0.552; -0.014; -0.020; -0.438; 0.757 | — |
| SECONDARY Percent Change From Baseline in Bone Mineral Density of the Whole Body |
-0.391; 0.493; -1.122; -0.532; 0.521; -0.058 | — |
| SECONDARY Percent Change From Baseline in Procollagen Type 1 N-terminal Propeptide (P1NP) |
-4.55; 5.90; 4.37; 1.18; -0.71; 8.46 | — |
| SECONDARY Percent Change From Baseline in Osteocalcin |
-0.19; 6.61; -7.02; 4.95; -4.09; 9.53 | — |
| SECONDARY Percent Change From Baseline in Bone-specific Alkaline Phosphatase (BSAP) |
-0.07; -4.51; -8.52; 10.25; 2.22; 5.82 | — |
| SECONDARY Percent Change From Baseline in Serum C-telopeptide (sCTX) |
-7.31; 12.29; -11.32; 8.05; -7.07; -10.15 | — |
| SECONDARY Percent Change From Baseline in Intact Parathyroid Hormone (iPTH) |
-5.72; -13.34; -2.09; 7.94; -1.06; 8.68 | — |
| SECONDARY Percent Change From Baseline in Sclerostin |
-5.6; 3135.6; 5630.4; 6087.5; 7532.4; 2809.3 | — |
| SECONDARY Change From Baseline in Ionized Calcium |
0.05; 0.12; 0.06; -0.07; -0.05; -0.14 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy males and females between 45 to 80 years of age
- Postmenopausal females
- Low bone mineral density, defined by bone mineral density (BMD) T-scores between -1.0 and -2.5, inclusive, for the lumbar spine [L1-L4] or total evaluable vertebrae [if fewer than L1-L4] or total hip)
- 25-hydroxyvitamin D ≥ 20 ng/mL
- Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
Exclusion Criteria
- Osteoporosis defined by bone mineral density (BMD) T-scores < -2.5 for the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4) or total hip
- Diagnosed with any condition that would affect bone metabolism
- Previous exposure to AMG 785
Data sourced from ClinicalTrials.gov (NCT01825785). 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.