NCT00293813

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 27, 2010

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

1.8 years

First QC Date

February 17, 2006

Results QC Date

December 22, 2009

Last Update Submit

July 18, 2014

Conditions

Postmenopausal Osteoporosis

Keywords

Post MenopausalOsteoporosisMicroCTAmgendenosumabExtreme CTXCTFosamaxAlendronate

Outcome Measures

Primary Outcomes (1)

  • Cortical Thickness of Radius by XtremeCT Percent Change From Baseline at Month 12

    Cortical Thickness measured by XtremeCT.

    12 months

Secondary Outcomes (1)

  • Cortical Thickness of Tibia by XtremeCT Percent Change From Baseline at Month 12

    12 months

Study Arms (3)

3

PLACEBO COMPARATOR

Placebo for denosumab and placebo for alendronate

Drug: Placebo

1

EXPERIMENTAL

denosumab and placebo for alendronate

Drug: Denosumab

2

ACTIVE COMPARATOR

Placebo for denosumab and alendronate

Drug: Alendronate

Interventions

AlendronateDRUG

Alendronate 70 mg PO QW

2
DenosumabDRUG

denosumab 60 mg SC q 6 mos

1
PlaceboDRUG

Placebo for alendronate and placebo for denosumab

3

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20222106BACKGROUND

  • 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.

    PMID: 24275677BACKGROUND

  • Hu YJ, Chines A, Shi Y, Seeman E, Guo XE. The effect of denosumab and alendronate on trabecular plate and rod microstructure at the distal tibia and radius: A post-hoc HR-pQCT study. Bone. 2022 Jan;154:116187. doi: 10.1016/j.bone.2021.116187. Epub 2021 Sep 14.

    PMID: 34530172DERIVED

Related Links

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

AlendronateDenosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2008

Study Completion

August 1, 2008

Last Updated

July 25, 2014

Results First Posted

January 27, 2010

Record last verified: 2014-07