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Study of Transitioning From Alendronate to Denosumab

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
alendronate
Denosumab (AMG 162)
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, clinical trial, postmenopausal osteoporosis, alendronate, total hip bone mineral density

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    denosumab

    alendronate

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Percent Change From Baseline in Lumbar Spine 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.
    Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
    Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.

    Full Information

    First Posted
    September 14, 2006
    Last Updated
    June 30, 2011
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00377819
    Brief Title
    Study of Transitioning From Alendronate to Denosumab
    Official Title
    A Randomized Study to Evaluate Safety and Efficacy of Transitioning Therapy From Alendronate to Denosumab (AMG 162) in Postmenopausal Women With Low Bone Mineral Density
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2006 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    July 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postmenopausal Osteoporosis
    Keywords
    RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, clinical trial, postmenopausal osteoporosis, alendronate, total hip bone mineral density

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    504 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    denosumab
    Arm Type
    Experimental
    Arm Title
    alendronate
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    alendronate
    Intervention Description
    70 mg oral QW
    Intervention Type
    Drug
    Intervention Name(s)
    Denosumab (AMG 162)
    Intervention Description
    60 mg SC q 6 mos
    Primary Outcome Measure Information:
    Title
    Percent Change From Baseline in Total Hip Bone Mineral Density
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
    Time Frame
    Baseline, 12 months
    Secondary Outcome Measure Information:
    Title
    Percent Change From Baseline in Lumbar Spine Bone Mineral Density
    Description
    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using [(12 month value - baseline value) / baseline value]*100.
    Time Frame
    Baseline, 12 months
    Title
    Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)
    Description
    Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using [(3 month value - baseline value) / baseline value]*100.
    Time Frame
    Baseline, 3 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19594293
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    31776637
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    22152181
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    20533525
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
    Description
    Notice regarding posted summaries of trial results
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

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    Study of Transitioning From Alendronate to Denosumab

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