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

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ClinicalTrials.gov Identifier: NCT01796301
Recruitment Status : Completed
First Posted : February 21, 2013
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Romozosumab Drug: Teriparatide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 31, 2013
Actual Primary Completion Date : May 14, 2015
Actual Study Completion Date : May 14, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Romosozumab
Participants received 210 mg romosozumab administered by subcutaneous injection once a month for 12 months.
Drug: Romozosumab
Administered by subcutaneous injection once a month.
Other Name: AMG 785

Active Comparator: Teriparatide
Participants received 20 μg/day teriparatide administered by subcutaneous injection for 12 months.
Drug: Teriparatide
Administered by subcutaneous injection once a day.
Other Names:
  • Forteo
  • Forsteo




Primary Outcome Measures :
  1. Percent Change From Baseline Through Month 12 in Total Hip Bone Mineral Density (BMD) [ Time Frame: 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 :
  1. Percent Change From Baseline in Total Hip BMD at Month 6 [ Time Frame: Baseline and month 6 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  2. Percent Change From Baseline in Total Hip BMD at Month 12 [ Time Frame: Baseline and month 12 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  3. Percent Change From Baseline in Cortical BMD by Quantitative Computed Tomography (QCT) at the Total Hip at Month 6 [ Time Frame: Baseline and month 6 ]
    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

  4. Percent Change From Baseline in Cortical BMD by QCT at the Total Hip at Month 12 [ Time Frame: Baseline and month 12 ]
    Cortical BMD was measured by quantitative computed tomography (QCT) at the total hip.

  5. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 6 [ Time Frame: Baseline and month 6 ]
    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

  6. Percent Change From Baseline in Integral BMD by QCT at the Total Hip at Month 12 [ Time Frame: Baseline and month 12 ]
    Integral BMD was measured by quantitative computed tomography (QCT) at the total hip.

  7. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 6 [ Time Frame: Baseline and month 6 ]
    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

  8. Percent Change From Baseline in Estimated Strength at the Total Hip at Month 12 [ Time Frame: Baseline and month 12 ]
    Total hip estimated strength was assessed by finite element analysis (FEA) of QCT scans.

  9. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 6 [ Time Frame: Baseline and month 6 ]
    Total hip integral BMC was measured using quantitative computed tomography (QCT).

  10. Percent Change From Baseline in Total Hip Integral Bone Mineral Content (BMC) by QCT at Month 12 [ Time Frame: Baseline and month 12 ]
    Total hip integral BMC was measured using quantitative computed tomography (QCT).

  11. Percent Change From Baseline in Femoral Neck BMD at Month 6 [ Time Frame: Baseline and month 6 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  12. Percent Change From Baseline in Femoral Neck BMD at Month 12 [ Time Frame: Baseline and month 12 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  13. Percent Change From Baseline in Lumbar Spine BMD at Month 6 [ Time Frame: Baseline and month 6 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

  14. Percent Change From Baseline in Lumbar Spine BMD at Month 12 [ Time Frame: Baseline and month 12 ]
    Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796301


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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01796301     History of Changes
Other Study ID Numbers: 20080289
2012-002948-24 ( EudraCT Number )
First Posted: February 21, 2013    Key Record Dates
Results First Posted: November 8, 2018
Last Update Posted: November 8, 2018
Last Verified: September 2018

Keywords provided by Amgen:
Postmenopausal Osteoporosis

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents