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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293813
• Other study ID #: 20050179
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2006
• Last updated: July 18, 2014
• Start date: May 2006
• Est. completion date: August 2008

Study information

• Verified date: July 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: CCPPRB Central Ethics CommitteeUnited States: Food and Drug AdministrationUnited States: Western Institutional Review BoardArgentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica)Argentina: Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: August 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Alendronate
Alendronate 70 mg PO QW
• Denosumab
denosumab 60 mg SC q 6 mos
• Placebo
Placebo for alendronate and placebo for denosumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12	Cortical Thickness measured by XtremeCT.	12 months	No
Secondary	Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12	Cortical Thickness measured by XtremeCT.	12 months	No

External Links

•   AmgenTrials clinical trials website