Overview

Denosumab Adherence Preference Satisfaction Study

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
Female
Summary
The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Treatments:
Alendronate
Denosumab
Criteria
Inclusion Criteria:

- Ambulatory postmenopausal women based on medical history

- > or = 55 years of age at the start of screening

- Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral
neck OR total hip that occur within the specified ranges based on the particular
scanner that is used. At least 2 lumbar vertebrae must be evaluable by Dual X-ray
Absorptiometry (DXA), or at least one hip must be evaluable by DXA

- Provide written informed consent before any study specific procedure is performed.

Exclusion Criteria:

- Any disorder that compromises the ability of the subject to give written informed
consent and/or to comply with study procedures

- Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on
thyroid hormone replacement therapy are allowed

- Current hyper- or hypoparathyroidism

- Current hypo- or hyper calcemia based on the central laboratory reference ranges for
albumin-adjusted serum calcium

- Rheumatoid arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or
cirrhosis of the liver

- Any metabolic bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may
interfere with the interpretation of the findings

- Any symptomatic vertebral fracture within 3 months prior to screening

- Previous participation in clinical trials with denosumab

- Vitamin D deficiency [25(OH) vitamin D level < 20 ng/mL (<49.9 nmol/L)]

- Contraindicated to alendronate therapy; contraindications for alendronate therapy
include:

1. Abnormalities of the esophagus, which delay esophageal emptying such as stricture
or achalasia.

2. Inability to stand or sit upright for at least 30 minutes.

3. Hypersensitivity to alendronate (ALN) or other constituents of ALN tablets.

- Any known prior bisphosphonate use

- Currently enrolled in or has not yet completed at least 1 month since ending other
investigational device or drug trail (s), or subject is receiving other
investigational agent(s).