Denosumab Adherence Preference Satisfaction Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: alendronate; denosumab
Intervention description: Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1.; Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.
Intervention MeSH terms: Denosumab; Alendronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 250.0
Sex: Female
Minimum age: 55 Years
Healthy volunteers: No
Keywords: osteoporosis; low bone mineral density; alendronate; denosumab; adherence; preference; satisfaction; postmenopausal; women

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).
    

Eligibility 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).