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
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
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
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
Learn more about this trial
Study of Transitioning From Alendronate to Denosumab
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