An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment With Romosozumab in Postmenopausal Women With Osteoporosis Previously Treated With Bisphosphonate Therapy

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Romozosumab
* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Romosozumab<br>Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months. | Drug: Romozosumab<br>* Administered by subcutaneous injection once a month.<br>* Other names: AMG 785;|
| Active Comparator: Teriparatide<br>Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months. | Drug: Teriparatide<br>* Administered by subcutaneous injection once a day.<br>* Other names: Forsteo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) | 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. | Baseline, month 6 and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Hip BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 | 
| Percent Change From Baseline in Total Hip BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 12 | 
| Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 6 | 
| Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 | Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 12 | 
| Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 6 | 
| Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 | Integral BMD was measured by quantitative computed tomography (QCT) at the total hip. | Baseline and month 12 | 
| Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. | Baseline and month 6 | 
| Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 | Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans. | Baseline and month 12 | 
| Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 | Total hip integral BMC was measured using quantitative computed tomography (QCT). | Baseline and month 6 | 
| Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 | Total hip integral BMC was measured using quantitative computed tomography (QCT). | Baseline and month 12 | 
| Percent Change From Baseline in Femoral Neck BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 | 
| Percent Change From Baseline in Femoral Neck BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 12 | 
| Percent Change From Baseline in Lumbar Spine BMD at Month 6 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 6 | 
| Percent Change From Baseline in Lumbar Spine BMD at Month 12 | Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA). | Baseline and month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal Osteoporosis