Study of Transitioning From Alendronate to Denosumab

Amgen

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: alendronate; Drug: Denosumab (AMG 162)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00377819

20050234

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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504 participants in 2 patient groups

denosumab

Experimental group

Treatment:

Drug: Denosumab (AMG 162)

alendronate

Active Comparator group

Treatment:

Drug: alendronate