Denosumab Adherence Preference Satisfaction Study

Amgen

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: alendronate; Drug: denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00518531

20060232

DAPS

Details and patient eligibility

About

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).

Enrollment: 250 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Treatment Sequence B

Other group

Description:

When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2).

Treatment:

Drug: denosumab

Drug: alendronate

Treatment Sequence A

Other group

Description:

When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2).

Treatment:

Drug: denosumab

Drug: alendronate