A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Information source: Amgen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: Alendronate (Drug); Denosumab (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Summary
This study is structured to estimate the effect of denosumab, compared to placebo and
alendronate, on several bone parameters.
Clinical Details
Official title: A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12
Secondary outcome: Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12
Eligibility
Minimum age: 50 Years.
Maximum age: 70 Years.
Gender(s): Female.
Criteria:
Key Inclusion Criteria:
- Postmenopausal, ambulatory women between 50 and 70 years old who are generally in
good health.
- Must have low bone mineral density and meet specific eligibility criteria.
Key Exclusion Criteria:
- Subjects must not currently be receiving any medication that affects bone metabolism or
have an underlying condition that affects their ability to take alendronate or receive
denosumab.
Locations and Contacts
Additional Information
AmgenTrials clinical trials website
Related publications: Seeman E, Delmas PD, Hanley DA, Sellmeyer D, Cheung AM, Shane E, Kearns A, Thomas T, Boyd SK, Boutroy S, Bogado C, Majumdar S, Fan M, Libanati C, Zanchetta J. Microarchitectural deterioration of cortical and trabecular bone: differing effects of denosumab and alendronate. J Bone Miner Res. 2010 Aug;25(8):1886-94. doi: 10.1002/jbmr.81. Zebaze RM, Libanati C, Austin M, Ghasem-Zadeh A, Hanley DA, Zanchetta JR, Thomas T, Boutroy S, Bogado CE, Bilezikian JP, Seeman E. Differing effects of denosumab and alendronate on cortical and trabecular bone. Bone. 2014 Feb;59:173-9. doi: 10.1016/j.bone.2013.11.016. Epub 2013 Nov 22.
Starting date: May 2006
Last updated: July 18, 2014
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