Post Menopausal Osteoporosis Clinical Trial
Official title:
A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
Verified date | March 2020 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 643 |
Est. completion date | January 7, 2015 |
Est. primary completion date | January 7, 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 55 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Research Site | Box Hill | Victoria |
Australia | Research Site | Geelong | Victoria |
Australia | Research Site | Maroubra | New South Wales |
Australia | Research Site | Parkville | Victoria |
Australia | Research Site | Penrith | New South Wales |
Australia | Research Site | St Leonards | New South Wales |
Belgium | Research Site | Brussel | |
Belgium | Research Site | Brussels | |
Belgium | Research Site | Bruxelles | |
Belgium | Research Site | Bruxelles | |
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 | Research Site | Yvoir | |
Canada | Research Site | Calgary | Alberta |
Canada | Research Site | Halifax | Nova Scotia |
Canada | Research Site | Quebec | |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Vancouver | British Columbia |
Denmark | Research Site | Aalborg | |
Denmark | Research Site | Ballerup | |
Denmark | Research Site | Vejle | |
Poland | Research Site | Bialystok | |
Poland | Research Site | Kraków | |
Poland | Research Site | Torun | |
Poland | Research Site | Warszawa | |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Granada | Andalucía |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
United States | Research Site | Bethesda | Maryland |
United States | Research Site | Detroit | Michigan |
United States | Research Site | Hagerstown | Maryland |
United States | Research Site | Houston | Texas |
United States | Research Site | Lakewood | Colorado |
United States | Research Site | Longmont | Colorado |
United States | Research Site | Santa Monica | California |
United States | Research Site | Washington | District of Columbia |
United States | Research Site | West Haverstraw | New York |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Australia, Belgium, Canada, Denmark, Poland, Spain,
Chotiyarnwong P, McCloskey E, Eastell R, McClung MR, Gielen E, Gostage J, McDermott M, Chines A, Huang S, Cummings SR. A Pooled Analysis of Fall Incidence From Placebo-controlled Trials of Denosumab. J Bone Miner Res. 2020 Jan 30. doi: 10.1002/jbmr.3972. [Epub ahead of print] — View Citation
Miller PD, Pannacciulli N, Brown JP, Czerwinski E, Nedergaard BS, Bolognese MA, Malouf J, Bone HG, Reginster JY, Singer A, Wang C, Wagman RB, Cummings SR. Denosumab or Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates. J Clin Endocrinol Metab. 2016 Aug;101(8):3163-70. doi: 10.1210/jc.2016-1801. Epub 2016 Jun 6. — View Citation
Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 - Non-inferiority Analysis | 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. | Baseline and Month 12 | |
Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 - Non-inferiority Analysis | BMD of the hip was measured by DXA. DXA scans were analyzed by a central imaging facility. | Baseline and Month 12 | |
Secondary | Percent Change From Baseline in Lumbar Spine BMD at Month 12 - Superiority Analysis | Baseline and Month 12 | ||
Secondary | Percent Change From Baseline in Total Hip BMD at Month 12 - Superiority Analysis | Baseline and Month 12 |
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