NCT00091793

Brief Summary

This study will determine whether treatment with AMG 162 can prevent lumbar spine bone loss in both early and late postmenopausal women with osteopenia, and to further test the safety and tolerability of AMG 162 in this population.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
332

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_3

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

Study Start

First participant enrolled

August 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2004

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 26, 2010

Completed
Last Updated

December 31, 2010

Status Verified

December 1, 2010

Enrollment Period

4.5 years

First QC Date

September 17, 2004

Results QC Date

December 22, 2009

Last Update Submit

December 22, 2010

Conditions

Postmenopausal Osteoporosis

Keywords

OsteoporosisPostmenopausal

Outcome Measures

Primary Outcomes (1)

  • Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

    24 Months

Secondary Outcomes (8)

  • Total Hip Bone Mineral Density Percent Change From Baseline at Month 24

    24 Months

  • Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24

    24 Months

  • Trochanter Bone Mineral Density Percent Change From Baseline at Month 24

    24 months

  • Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24

    24 months

  • Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24

    24 months

  • +3 more secondary outcomes

Study Arms (2)

AMG 162

EXPERIMENTAL

60 mg/mL denosumab given day 1, month 6, month 12 and month 18

Drug: AMG 162

Placebo

PLACEBO COMPARATOR

Placebo given day 1, month 6, month 12 and month 18

Drug: Placebo

Interventions

AMG 162DRUG

60 mg/mL denosumab given day 1, month 6, month 12 and month 18

AMG 162
PlaceboDRUG

Placebo given at day 1, month 6, month 12 and month 18

Placebo

Eligibility Criteria

AgeUp to 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Eligibility Criteria \- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1.

    PMID: 18381571RESULT

  • Engelke K, Libanati C, Liu Y, Wang H, Austin M, Fuerst T, Stampa B, Timm W, Genant HK. Quantitative computed tomography (QCT) of the forearm using general purpose spiral whole-body CT scanners: accuracy, precision and comparison with dual-energy X-ray absorptiometry (DXA). Bone. 2009 Jul;45(1):110-8. doi: 10.1016/j.bone.2009.03.669. Epub 2009 Apr 2.

    PMID: 19345291RESULT

  • Bone HG, Bolognese MA, Yuen CK, Kendler DL, Miller PD, Yang YC, Grazette L, San Martin J, Gallagher JC. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 Apr;96(4):972-80. doi: 10.1210/jc.2010-1502. Epub 2011 Feb 2.

    PMID: 21289258DERIVED

Related Links

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, 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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 17, 2004

First Posted

September 21, 2004

Study Start

August 1, 2004

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

December 31, 2010

Results First Posted

January 26, 2010

Record last verified: 2010-12