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

Phase 3

Completed

Conditions: Postmenopausal Osteoporosis

Interventions: Drug: Romozosumab
Drug: Teriparatide

Registration Number: NCT01796301

Lead Sponsor: Amgen

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 436

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Romosozumab	Romozosumab	Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Teriparatide	Teriparatide	Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD)	Baseline, month 6 and month 12	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.

Secondary Outcome Measures

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