Phase 4
N=643
Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
Post Menopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT01732770 ↗Enrolled (actual)
643
Serious AEs
8.4%
Results posted
Jan 2016
Primary outcome: Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis — 1.1; 3.2 percent change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Denosumab (Biological); Zoledronic Acid (Drug); Placebo to Denosumab (Drug); Placebo to Zoledronic Acid (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Amgen
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis |
1.1; 3.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis |
0.6; 1.9 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis |
1.1; 3.2 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis |
0.6; 1.9 | <0.0001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01732770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.