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

Completed · Phase 4 · Has a placebo group

Conditions studied: Post Menopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT01732770

Run by

Amgen

People needed

643

Starts

2012-11-07

Expected to finish

2015-01-07

Last updated by the study team

2020-03-10

Who can join

Age: 55 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Santa Monica, California, United States
• Research Site — Lakewood, Colorado, United States
• Research Site — Longmont, Colorado, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — Hagerstown, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — West Haverstraw, New York, United States
• Research Site — Houston, Texas, United States
• Research Site — Maroubra, New South Wales, Australia
• Research Site — Penrith, New South Wales, Australia
• Research Site — St Leonards, New South Wales, Australia
• Research Site — Box Hill, Victoria, Australia
• Research Site — Geelong, Victoria, Australia
• Research Site — Parkville, Victoria, Australia
• Research Site — Brussels, Belgium
• Research Site — Brussels, Belgium
• Research Site — Brussels, Belgium
• Research Site — Brussels, Belgium
• Research Site — Genk, Belgium
• Research Site — Leuven, Belgium
• Research Site — Liège, Belgium
• Research Site — Merksem, Belgium
• Research Site — Tessenderlo, Belgium
• Research Site — Wilrijk, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.