Study of Transitioning From Alendronate to Denosumab

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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denosumab

Group Type EXPERIMENTAL

Denosumab (AMG 162)

Intervention Type DRUG

60 mg SC q 6 mos

alendronate

Group Type ACTIVE_COMPARATOR

alendronate

Intervention Type DRUG

70 mg oral QW

Interventions

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alendronate

70 mg oral QW

Intervention Type DRUG

Denosumab (AMG 162)

60 mg SC q 6 mos

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No