Study of Transitioning From Alendronate to Denosumab

Amgen504 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

504

Conditions

Postmenopausal Osteoporosis

Interventions

alendronateDRUG

70 mg oral QW

Denosumab (AMG 162)DRUG

60 mg SC q 6 mos

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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