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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00293813
Other study ID # 20050179
Secondary ID
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


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
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