Phase 3
Completed N=294
A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT02016716 ↗Enrolled (actual)
294
Serious AEs
5.4%
Results posted
Nov 2018
Primary outcomePrimary: Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine — 0.8; 9.6; 9.2 percent change
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine |
0.8; 9.6; 9.2 | — |
| SECONDARY Percent Change From Baseline in Total Hip BMD |
-0.0; 3.9; 3.4 | — |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD |
-0.5; 3.1; 2.6 | — |
| SECONDARY Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) |
2.000; 96.296; 97.435; -9.601; 23.960; 16.216 | — |
| SECONDARY Percent Change From Baseline in Serum C-Telopeptide (CTX) |
0.282; -23.158; -21.456; -5.687; -11.219; -5.473 | — |
Eligibility Criteria
Inclusion Criteria
Postmenopausal women with osteoporosis at high risk for fracture defined as
- BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND
- a history of fragility fracture or at least 2 other risk factors
Exclusion Criteria
- BMD T score < -3.50 at the total hip or femoral neck.
- History of hip fracture.
- History of metabolic or bone disease (except osteoporosis).
- Use of agents affecting bone metabolism.
- Vitamin D insufficiency.
- History of solid organ or bone marrow transplants.
- Hyper- or hypocalcemia.
- Hyper- or hypothyroidism.
- Hyper- or hypoparathyroidism.
Data sourced from ClinicalTrials.gov (NCT02016716). 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.