Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Phase 4

Completed

• Conditions: Post Menopausal Osteoporosis
• Interventions: Biological: Denosumab; Drug: Zoledronic Acid; Drug: Placebo to Zoledronic Acid; Drug: Placebo to Denosumab

• Registration Number: NCT01732770
• Lead Sponsor: Amgen

Brief Summary

This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-07
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-20
• Study First Posted: 2012-11-26
• Primary Completion: 2015-01-07
• Study Completion: 2015-01-07
• Results First Submitted: 2015-12-09
• Results First Submitted QC: 2015-12-17
• Results First Posted: 2016-01-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 643

Inclusion Criteria

• Ambulatory postmenopausal women.
• Age 55 years or older
• Subject has provided informed consent prior to any study specific procedures
• Received oral bisphosphonate therapy for osteoporosis at least 2 years prior to screening visit
• Screening BMD (g/cm²) values at the lumbar spine, total hip or femoral neck values of equal to or less than those listed in the protocol.
• At least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray absorptiometry (DXA) at the screening visit

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Exclusion Criteria

• Received other osteoporosis treatment or bone active treatment

• Evidence of history of any of the following:

  • hyperthyroidism (stable on antithyroid therapy is allowed)
  • hypothyroidism (stable on thyroid replacement therapy is allowed)
  • hypo- or hyperparathyroidism
  • hypo- or hypercalcemia based on the central laboratory reference ranges
  • Recent tooth extraction (within 6 months of screening visit)
  • Paget disease of bone (subject report or chart review)
  • other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)

• Abnormalities of the following per central laboratory reference ranges:

  • vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be allowed and subjects may be re-screened
  • hypercalcemia
  • elevated transaminases ≥ 2.0 x upper limits of normal (ULN)

• History of any solid organ or bone marrow transplant

• Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years

• Known intolerance to calcium or vitamin D supplements

• Self-reported alcohol or drug abuse within 12 months prior to screening

• Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)

• History or evidence of any other clinically significant disorder, condition or disease that in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab 60 mg	Denosumab	Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
Denosumab 60 mg	Placebo to Zoledronic Acid	Participants received denosumab 60 mg subcutaneous injection once every 6 months for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
Zoledronic Acid 5 mg	Placebo to Denosumab	Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
Zoledronic Acid 5 mg	Zoledronic Acid	Participants received zoledronic acid 5 mg by intravenous infusion on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis	Baseline and Month 12	Bone mineral density (BMD) of the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). DXA scans were analyzed by a central imaging facility.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis	Baseline and Month 12	BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility.
Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis	Baseline and Month 12
Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis	Baseline and Month 12

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain