NCT00377819

Brief Summary

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
504

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 3, 2010

Completed
Last Updated

July 11, 2011

Status Verified

June 1, 2011

Enrollment Period

1.5 years

First QC Date

September 14, 2006

Results QC Date

July 1, 2010

Last Update Submit

June 30, 2011

Conditions

Postmenopausal Osteoporosis

Keywords

RANKLRANKdenosumabAMG 162osteoporosisbone turnoverbone mineral densityclinical trialpostmenopausal osteoporosisalendronatetotal hip bone mineral density

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Total Hip Bone Mineral Density

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.

    Baseline, 12 months

Secondary Outcomes (2)

  • Percent Change From Baseline in Lumbar Spine Bone Mineral Density

    Baseline, 12 months

  • Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)

    Baseline, 3 months

Study Arms (2)

denosumab

EXPERIMENTAL
Drug: Denosumab (AMG 162)

alendronate

ACTIVE COMPARATOR
Drug: alendronate

Interventions

alendronateDRUG

70 mg oral QW

alendronate
Denosumab (AMG 162)DRUG

60 mg SC q 6 mos

denosumab

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal females 55 yrs or older
  • Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
  • Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4

You may not qualify if:

  • Vitamin D deficiency
  • Administration of intravenous bisphosphonate, or
  • fluoride (except for dental treatment) or
  • strontium ranelate
  • Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
  • Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kendler DL, Roux C, Benhamou CL, Brown JP, Lillestol M, Siddhanti S, Man HS, San Martin J, Bone HG. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy. J Bone Miner Res. 2010 Jan;25(1):72-81. doi: 10.1359/jbmr.090716.

    PMID: 19594293RESULT

  • Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.

    PMID: 31776637DERIVED

  • Gold DT, Horne R, Coon CD, Price MA, Borenstein J, Varon SF, Satram-Hoang S, Macarios D. Development, reliability, and validity of a new Preference and Satisfaction Questionnaire. Value Health. 2011 Dec;14(8):1109-16. doi: 10.1016/j.jval.2011.06.010. Epub 2011 Oct 1.

    PMID: 22152181DERIVED

  • Reid IR, Miller PD, Brown JP, Kendler DL, Fahrleitner-Pammer A, Valter I, Maasalu K, Bolognese MA, Woodson G, Bone H, Ding B, Wagman RB, San Martin J, Ominsky MS, Dempster DW; Denosumab Phase 3 Bone Histology Study Group. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies. J Bone Miner Res. 2010 Oct;25(10):2256-65. doi: 10.1002/jbmr.149.

    PMID: 20533525DERIVED

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

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 18, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2008

Study Completion

July 1, 2008

Last Updated

July 11, 2011

Results First Posted

August 3, 2010

Record last verified: 2011-06