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An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Phase 3 trial testing Romozosumab in Postmenopausal Osteoporosis in 436 participants. Completed in 14 May 2015.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 436 |
| Start date | 31 January 2013 |
| Primary completion | 14 May 2015 |
| Estimated completion | 14 May 2015 |
| Sites | 50 locations across Denmark, Colombia, Belgium, United Kingdom, Hungary, Poland, Argentina, Canada |
Amgen — full company profile →
Adults 55 to 90, female only, with Postmenopausal Osteoporosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). Percent change from baseline through month 12 is the average of the treatment effect at months 6 and 12.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.6 | ± 0.2 |
| Romosozumab | 2.6 | ± 0.2 |
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.8 | ± 0.2 |
| Romosozumab | 2.3 | ± 0.2 |
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.5 | ± 0.2 |
| Romosozumab | 2.9 | ± 0.2 |
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -2.7 | ± 0.2 |
| Romosozumab | 0.7 | ± 0.2 |
Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -3.6 | ± 0.3 |
| Romosozumab | 1.1 | ± 0.3 |
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.8 | ± 0.2 |
| Romosozumab | 2.3 | ± 0.2 |
Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.2 | ± 0.2 |
| Romosozumab | 3.4 | ± 0.2 |
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -1.0 | ± 0.2 |
| Romosozumab | 2.1 | ± 0.2 |
Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.7 | ± 0.4 |
| Romosozumab | 2.5 | ± 0.4 |
Total hip integral BMC was measured using quantitative computed tomography (QCT).
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -0.7 | ± 0.2 |
| Romosozumab | 2.4 | ± 0.2 |
Total hip integral BMC was measured using quantitative computed tomography (QCT).
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | 0.0 | ± 0.2 |
| Romosozumab | 3.6 | ± 0.2 |
Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).
| Group | Value | 95% CI |
|---|---|---|
| Teriparatide | -1.1 | ± 0.3 |
| Romosozumab | 2.1 | ± 0.3 |
Time frame: 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Teriparatide | Romosozumab |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Bone marrow failure | Blood and lymphatic system disorders | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Arrhythmia supraventricular | Cardiac disorders | — | — |
| Bifascicular block | Cardiac disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Cardiac failure chronic | Cardiac disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Sinus bradycardia | Cardiac disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Abdominal pain lower | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Large intestinal ulcer | Gastrointestinal disorders | — | — |
| Pancreatitis acute | Gastrointestinal disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| Diverticulitis | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Reaction | System | Teriparatide | Romosozumab |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — |
| Hypercalcaemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Atrial fibrillation, Abdominal pain, Pneumonia, Bone marrow failure, Angina pectoris, Arrhythmia supraventricular, Bifascicular block, Bradycardia.
Data from ClinicalTrials.gov NCT01796301 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01796301.
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