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CompletedNCT00091793Updated Dec 31, 2010Results posted

Study to Evaluate AMG 162 in the Prevention of Postmenopausal Osteoporosis

A Phase 3 interventional study of AMG 162 and Placebo in Postmenopausal Osteoporosis, sponsored by Amgen. Completed. Open to female participants aged Up to 90 Years. Per ClinicalTrials.gov, last updated 2010-12-31.

Sponsored by Amgen · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
332
Allocation
Randomized
Ages
Up to 90 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Postmenopausal Osteoporosis

Keywords

  • Osteoporosis
  • Postmenopausal
03

In context

Osteoporosis, Postmenopausal

337 studies on the registry are indexed under Osteoporosis, Postmenopausal; 29 are open to participants now.

This study's enrollment of 332 is above the median of 110 across 265 interventional studies indexed under Osteoporosis, Postmenopausal.

Browse Osteoporosis, Postmenopausal studies →

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

Browse Amgen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

Eligibility Criteria

- Postmenopausal women with Osteopenia (lumbar spine bone mineral density T-score between 1.0 and -2.5)

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
332 participants (actual)

Study arms

  • Experimental
    AMG 162

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

    Drug: AMG 162

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugAMG 162

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

  • DrugPlacebo

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

06

What researchers measure

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.

    Time frame: 24 Months

Secondary outcomes

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

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

    Time frame: 24 Months

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

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

    Time frame: 24 Months

  3. Trochanter Bone Mineral Density Percent Change From Baseline at Month 24

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

    Time frame: 24 months

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

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

    Time frame: 24 months

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

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

    Time frame: 24 months

  6. Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

    Time frame: 24 months

  7. Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

    Time frame: 24 months

  8. Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

    Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

    Time frame: 24 months

07

Results

Posted Jan 26, 2010

Participant flow

Participant flow — Overall Study
MilestoneDenosumab 60 mg Q6MPlacebo
Started166166
Completed142144
Not completed2422
Withdrew: Adverse event12
Withdrew: Withdrawal by subject1015
Withdrew: Ineligibility determined20
Withdrew: Lost to follow-up75
Withdrew: Noncompliance20
Withdrew: Other20

Outcome measures

PrimaryLumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24

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

Time frame:
24 Months
Reported as:
Least squares mean · Percent Change from Baseline
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 246.5 (5.8 to 7.2)-.6 (-1.2 to .1)
Statistical analysis
  • Denosumab 60 mg Q6M vs Placebo · ANCOVA · p = <0.0001 · Mean difference (final values): 7 · 95% CI 6.2 to 7.8
SecondaryTotal Hip Bone Mineral Density Percent Change From Baseline at Month 24

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

Time frame:
24 Months
Reported as:
Least squares mean · Percent Change from Baseline
Total Hip Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Total Hip Bone Mineral Density Percent Change From Baseline at Month 243.4 (3.0 to 3.7)-1.1 (-1.5 to -.8)
SecondaryFemoral Neck Bone Mineral Density Percent Change From Baseline at Month 24

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

Time frame:
24 Months
Reported as:
Least squares mean · Percent Change from Baseline
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 242.8 (2.3 to 3.3)-.9 (-1.4 to -.3)
SecondaryTrochanter Bone Mineral Density Percent Change From Baseline at Month 24

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

Time frame:
24 months
Reported as:
Least squares mean · Percent Change from Baseline
Trochanter Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Trochanter Bone Mineral Density Percent Change From Baseline at Month 245.2 (4.7 to 5.6)-.8 (-1.3 to -.3)
SecondaryDistal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24

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

Time frame:
24 months
Reported as:
Least squares mean · Percent Change from Baseline
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 241.4 (.9 to 1.9)-2.1 (-2.6 to -1.6)
SecondaryTotal Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24

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

Time frame:
24 months
Reported as:
Least squares mean · Percent Change from Baseline
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 242.4 (1.9 to 2.9)-1.4 (-1.9 to -.8)
SecondaryDistal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

Time frame:
24 months
Reported as:
Least squares mean · Percent Change from Baseline
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 248.7 (3 to 14.4)-.7 (-6.6 to 5.3)
SecondaryDistal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

Time frame:
24 months
Reported as:
Least squares mean · Percent Change from Baseline
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24.3 (-.1 to .8)-1.4 (-1.8 to -.9)
SecondaryDistal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24

Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).

Time frame:
24 months
Reported as:
Least squares mean · Percent Change from Baseline
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24
Percent Change from BaselineDenosumab 60 mg Q6MPlacebo
Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24.8 (0 to 1.6)-1.9 (-2.6 to -1.1)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—9/165 (5.5%)157/165 (95.2%)
Denosumab 60 mg Q6M—18/164 (11%)156/164 (95.1%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventPlaceboDenosumab 60 mg Q6M
PneumoniaInfections and infestations0/1653/164
DiverticulitisInfections and infestations0/1652/164
SepsisInfections and infestations0/1652/164
OsteoarthritisMusculoskeletal and connective tissue disorders0/1652/164
Colitis ischaemicGastrointestinal disorders0/1651/164
Colonic polypGastrointestinal disorders0/1651/164
AppendicitisInfections and infestations0/1651/164
CellulitisInfections and infestations0/1651/164
PyelonephritisInfections and infestations0/1651/164
Urinary tract infectionInfections and infestations0/1651/164
Most frequent other events
Showing 10 of 28
Most frequent other events
EventPlaceboDenosumab 60 mg Q6M
ArthralgiaMusculoskeletal and connective tissue disorders42/16541/164
NasopharyngitisInfections and infestations31/16536/164
Back painMusculoskeletal and connective tissue disorders33/16533/164
HeadacheNervous system disorders19/16526/164
Pain in extremityMusculoskeletal and connective tissue disorders20/16524/164
Upper respiratory tract infectionInfections and infestations22/16519/164
ConstipationGastrointestinal disorders8/16518/164
Urinary tract infectionInfections and infestations17/16518/164
InfluenzaInfections and infestations18/16515/164
Shoulder painMusculoskeletal and connective tissue disorders10/16517/164

Baseline characteristics

Age Continuous
Age Continuous(Years)Denosumab 60 mg Q6MPlaceboTotal
Mean59.8 ± 7.458.9 ± 7.559.4 ± 7.5
Sex: Female, Male
Sex: Female, Male(Participants)Denosumab 60 mg Q6MPlaceboTotal
Female166166332
Male000
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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. PubMed 18381571 ↗
  • 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. PubMed 19345291 ↗
  • 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. PubMed 21289258 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00091793
Lead sponsor
Amgen
First posted
Sep 21, 2004
Start date
Aug 2004
Primary completion
Feb 2009
Completion
Mar 2009
Results posted
Jan 26, 2010
Last update
Dec 31, 2010

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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