NCT00325468

Brief Summary

An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2006

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2012

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 30, 2013

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

4.9 years

First QC Date

May 10, 2006

Results QC Date

January 3, 2013

Last Update Submit

July 3, 2017

Conditions

Low Bone Mineral Density

Keywords

bone lossosteoporosis

Outcome Measures

Primary Outcomes (3)

  • Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

    8 years

  • Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

    8 years

  • Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8

    8 years

Secondary Outcomes (2)

  • Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8

    8 years

  • Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8

    8 years

Study Arms (1)

AMG 162

EXPERIMENTAL

AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

Drug: AMG 162

Interventions

AMG 162DRUG

AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42

AMG 162

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be ambulatory
  • Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
  • signed informed consent must be obtained before any study-specific procedures

You may not qualify if:

  • Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
  • Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
  • Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
  • Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Miller PD, Wagman RB, Peacock M, Lewiecki EM, Bolognese MA, Weinstein RL, Ding B, San Martin J, McClung MR. Effect of denosumab on bone mineral density and biochemical markers of bone turnover: six-year results of a phase 2 clinical trial. J Clin Endocrinol Metab. 2011 Feb;96(2):394-402. doi: 10.1210/jc.2010-1805. Epub 2010 Dec 15.

    PMID: 21159841DERIVED

Related Links

MeSH Terms

Conditions

Bone Diseases, MetabolicOsteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 12, 2006

Study Start

May 1, 2006

Primary Completion

March 28, 2011

Study Completion

August 2, 2012

Last Updated

August 1, 2017

Results First Posted

July 30, 2013

Record last verified: 2017-07