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Study of Transitioning From Alendronate to Denosumab

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00377819
Enrollment
504
Registered
2006-09-18
Start date
2006-09-30
Completion date
2008-07-31
Last updated
2011-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Keywords

RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, clinical trial, postmenopausal osteoporosis, alendronate, total hip bone mineral density

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.

Interventions

DRUGalendronate

70 mg oral QW

DRUGDenosumab (AMG 162)

60 mg SC q 6 mos

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent Change From Baseline in Total Hip Bone Mineral DensityBaseline, 12 monthsBone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.

Secondary

MeasureTime frameDescription
Percent Change From Baseline in Lumbar Spine Bone Mineral DensityBaseline, 12 monthsBone 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)Baseline, 3 monthsPercent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using \[(3 month value - baseline value) / baseline value\]\*100.

Participant flow

Recruitment details

First Subject Enrolled: 02-Oct-2006 Last Subject Enrolled: 07-Mar-2007

Participants by arm

ArmCount
Alendronate 70 mg QW
70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
251
Denosumab 60 mg Q6M
60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
253
Total504

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event23
Overall StudyDeath01
Overall StudyLost to Follow-up01
Overall StudyProtocol Violation11
Overall StudyWithdrawal by Subject104

Baseline characteristics

CharacteristicAlendronate 70 mg QWDenosumab 60 mg Q6MTotal
Age Continuous68.2 Years
STANDARD_DEVIATION 7.7
66.9 Years
STANDARD_DEVIATION 7.8
67.6 Years
STANDARD_DEVIATION 7.8
Race/Ethnicity, Customized
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Asian
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Black or African American
2 Participants0 Participants2 Participants
Race/Ethnicity, Customized
Hispanic or Latino
12 Participants11 Participants23 Participants
Race/Ethnicity, Customized
Japanese
1 Participants3 Participants4 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Other
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White or Caucasian
232 Participants238 Participants470 Participants
Sex: Female, Male
Female
251 Participants253 Participants504 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
101 / 249103 / 253
serious
Total, serious adverse events
16 / 24915 / 253

Outcome results

Primary

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.

Time frame: Baseline, 12 months

Population: Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Alendronate 70 mg QWPercent Change From Baseline in Total Hip Bone Mineral Density1.05 Percent Change
Denosumab 60 mg Q6MPercent Change From Baseline in Total Hip Bone Mineral Density1.9 Percent Change
p-value: <0.000195% CI: [0.44, 1.25]Repeated Measures Model
Secondary

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.

Time frame: Baseline, 12 months

Population: Participants with non-missing baseline evaluation and at least 1 non-missing post-baseline evaluation.

ArmMeasureValue (LEAST_SQUARES_MEAN)
Alendronate 70 mg QWPercent Change From Baseline in Lumbar Spine Bone Mineral Density1.85 Percent Change
Denosumab 60 mg Q6MPercent Change From Baseline in Lumbar Spine Bone Mineral Density3.03 Percent Change
p-value: <0.000195% CI: [0.63, 1.73]Repeated Measures Model
Secondary

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.

Time frame: Baseline, 3 months

Population: Participants with non-missing baseline evaluation and non-missing post-baseline evaluation at month 3.

ArmMeasureValue (MEDIAN)
Alendronate 70 mg QWPercent Change From Baseline in Serum C-Telopeptide-I (CTX-I)-4.2 Percent Change
Denosumab 60 mg Q6MPercent Change From Baseline in Serum C-Telopeptide-I (CTX-I)-63.3 Percent Change
p-value: <0.0001Van Elteren Stratified Rank Test

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026