Phase 2
Completed N=252
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
Postmenopausal Osteoporosis (PMO)
Source: ClinicalTrials.gov NCT01992159 ↗
Enrolled (actual)
252
Serious AEs
6.4%
Results posted
Mar 2019
Primary outcomePrimary: Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine — 0.9; 8.4; 13.3; 16.9 percent change — p=< 0.0001
Summary
The purpose of this study is to determine if treatment with romosozumab increases bone mineral density in Japanese women with postmenopausal osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to 12 Months in Bone Mineral Density at the Lumbar Spine |
0.9; 8.4; 13.3; 16.9 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline at 6 Months in Bone Mineral Density at the Lumbar Spine |
1.2; 6.5; 10.2; 13.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline at 6 Months in Bone Mineral Density at the Total Hip |
0.6; 1.2; 2.3; 3.2 | 0.1250 |
| SECONDARY Percent Change From Baseline to 12 Months in Bone Mineral Density at the Total Hip |
0.6; 2.1; 3.2; 4.7 | 0.0012 sig |
| SECONDARY Percent Change From Baseline to 6 Months in Bone Mineral Density at the Femoral Neck |
0.6; 1.0; 1.9; 3.3 | 0.2846 |
| SECONDARY Percent Change From Baseline to 12 Months in Bone Mineral Density at the Femoral Neck |
0.3; 1.9; 2.9; 3.8 | 0.0067 sig |
| SECONDARY Percent Change From Baseline in Procollagen Type 1 N-telopeptide (P1NP) |
-2.5; 43.4; 65.9; 81.5; -5.7; 32.2 | — |
| SECONDARY Percent Change From Baseline in Type 1 Collagen C-telopeptide (CTX) |
11.9; -28.0; -32.1; -42.0; 14.9; -18.0 | — |
| SECONDARY Percent Change From Baseline in Osteocalcin |
2.6; 6.5; 7.9; 5.5; -3.8; 26.5 | — |
| SECONDARY Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) |
1.6; 14.0; 17.0; 20.1; -0.5; 23.0 | — |
| SECONDARY Area Under the Curve Through Month 12 of P1NP |
554.5; 539.2; 638.5; 708.3 | 0.5084 |
Eligibility Criteria
Inclusion Criteria
Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip, or femoral neck)
Exclusion Criteria
- Severe osteoporosis
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
Data sourced from ClinicalTrials.gov (NCT01992159). 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.