Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis
This study is currently recruiting participants.
Verified January 2013 by Amgen
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01732770
First received: November 20, 2012
Last updated: January 9, 2013
Last verified: January 2013
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Purpose
This study will compare the effectiveness of Denosumab treatment Q6M with once yearly Zoledronic Acid treatment on Bone Mineral Density (BMD) at various skeletal sites.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Menopausal Osteoporosis |
Drug: Denosumab Drug: Zoledronic Acid |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]The primary objective of this study is to evaluate if the effect of administering Denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of Zoledronic Acid (5 mg intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy x-ray absorptiometry (DXA) of lumbar spine at 12 months
Secondary Outcome Measures:
- BMD by DXA of total hip at 12 months (non-inferiority); BMD by DXA of lumbar spine at 12 months (superiority); BMD by DXA of total hip at 12 months (superiority) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Secondary Objective(s): Compare the efficacy of administering Denosumab (60 mg SC Q6M) with that of Zoledronic Acid (5 mg IV once yearly) on the following: BMD by DXA of total hip at 12 months (non-inferiority); BMD by DXA of lumbar spine at 12 months (superiority); BMD by DXA of total hip at 12 months (superiority)
| Estimated Enrollment: | 620 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Denosumab 60 mg SC Q6M
Denosumab 60 mg SC Q6M for 12 months and placebo for Zoledronic Acid IV once yearly
|
Drug: Denosumab
Denosumab 60 mg SC Q6M for 12 months
|
|
Active Comparator: Zoledronic Acid 5 mg IV once yearly
Zoledronic Acid 5 mg IV once yearly and placebo for Denosumab SC Q6M for 12 months
|
Drug: Zoledronic Acid
Zoledronic Acid 5 mg IV once yearly
|
Detailed Description:
The rationale for this study is to evaluate whether patients who switch from oral biphosphonates to Denosumab have greater BMD gains than those who switch from oral biphosphonates to Zoledronic Acid.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732770
Contacts
| Contact: Amgen Call Center | 866-572-6436 |
Locations
| United States, California | |
| Research Site | Recruiting |
| Santa Monica, California, United States, 90404 | |
| United States, Colorado | |
| Research Site | Recruiting |
| Lakewood, Colorado, United States, 80227 | |
| Research Site | Recruiting |
| Longmont, Colorado, United States, 80501 | |
| United States, Maryland | |
| Research Site | Recruiting |
| Bethesda, Maryland, United States, 20817 | |
| Research Site | Recruiting |
| Hagerstown, Maryland, United States, 21740 | |
| United States, Michigan | |
| Research Site | Recruiting |
| Detroit, Michigan, United States, 48236 | |
| United States, Texas | |
| Research Site | Recruiting |
| Houston, Texas, United States, 77074 | |
| Australia, Victoria | |
| Research Site | Recruiting |
| Geelong, Victoria, Australia, 3220 | |
| Research Site | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Belgium | |
| Research Site | Recruiting |
| Leuven, Belgium, 3000 | |
| Research Site | Recruiting |
| Liège, Belgium, 4020 | |
| Research Site | Recruiting |
| Merksem, Belgium, 2170 | |
| Canada, Alberta | |
| Research Site | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Canada, British Columbia | |
| Research Site | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E1 | |
| Canada, Ontario | |
| Research Site | Recruiting |
| Toronto, Ontario, Canada, M9W 4L6 | |
| Research Site | Recruiting |
| Toronto, Ontario, Canada, M5C 2T2 | |
| Canada | |
| Research Site | Recruiting |
| Quebec, Canada, G1V 3M7 | |
| Spain | |
| Research Site | Recruiting |
| Granada, AndalucÃ-a, Spain, 18012 | |
| Research Site | Recruiting |
| Barcelona, Cataluña, Spain, 08036 | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01732770 History of Changes |
| Other Study ID Numbers: | 20110153, 2012-001821-28 |
| Study First Received: | November 20, 2012 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Office for Radiation Protection Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Agencia Española de Medicamentos y Productos Sanitarios Germany: Paul-Ehrlich-Institut Denmark: Danish Health and Medicines Authority Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
Zoledronic acid Diphosphonates Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013