Phase 3
Completed N=436
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Source: ClinicalTrials.gov NCT01796301 ↗Enrolled (actual)
436
Serious AEs
9.3%
Results posted
Nov 2018
Primary outcomePrimary: Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) — -0.6; 2.6 percent change — p=< 0.0001
◆ Published Evidence
Highly cited
463citations · ~51 / year
Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.
Summary
The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.
Linked Publications
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Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy: a randomised, open-label, phase 3 trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) |
-0.6; 2.6 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Hip BMD at Month 6 |
-0.8; 2.3 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Hip BMD at Month 12 |
-0.5; 2.9 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 |
-2.7; 0.7 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 |
-3.6; 1.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 |
-0.8; 2.3 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 |
-0.2; 3.4 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 |
-1.0; 2.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 |
-0.7; 2.5 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 |
-0.7; 2.4 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 |
0.0; 3.6 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD at Month 6 |
-1.1; 2.1 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD at Month 12 |
-0.2; 3.2 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 6 |
3.5; 7.2 | < 0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 12 |
5.4; 9.8 | < 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women, aged ≥ 55 to ≤ 90.
- Received oral bisphosphonate therapy for at least 3 years immediately prior to screening
- BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck
- History of nonvertebral fracture after age 50, or vertebral fracture.
Exclusion Criteria
- Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids:
- History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome.
- Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory.
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
Data sourced from ClinicalTrials.gov (NCT01796301) and the linked publication. 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.