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

• Status: Completed
• Trial end date: 2015-01-07
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab; Diphosphonates; Zoledronic Acid

Criteria

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

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