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Phase 3 N=250 Randomized Treatment

Denosumab Adherence Preference Satisfaction Study

Osteoporosis

Enrolled (actual)
250
Serious AEs
3.7%
Results posted
Jan 2014
Primary outcome: Primary: Adherence With Treatment in the First Treatment Period — 95; 111; 29; 15 Participants — p=0.0259

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
alendronate (Drug); denosumab (Drug)
Age
Adult, Older Adult · 55+ yrs
Sex
Female
Sponsor
Amgen
Primary completion
Jun 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Adherence With Treatment in the First Treatment Period
95; 111; 29; 15 0.0259 sig
SECONDARY
Adherence With Treatment in the Second Treatment Period
73; 98; 42; 8 <0.0001 sig
SECONDARY
Compliance With Treatment in the First Treatment Period
97; 114; 27; 12 0.0138 sig
SECONDARY
Compliance With Treatment in the Second Treatment Period
78; 99; 37; 7 <0.0001 sig
SECONDARY
Persistence With Treatment in the First Treatment Period
99; 114; 25; 12 0.0291 sig
SECONDARY
Persistence With Treatment in the Second Treatment Period
82; 103; 33; 3 <0.0001 sig
SECONDARY
Time to Non-adherence to Alendronate Treatment in the First Treatment Period
43.29
SECONDARY
Time to Non-adherence to Alendronate Treatment in the Second Treatment Period
39.45
SECONDARY
Time to Non-compliance to Alendronate Treatment in the First Treatment Period
43.75
SECONDARY
Time to Non-compliance to Alendronate Treatment in the Second Treatment Period
39.97
SECONDARY
Time to Non-persistence to Alendronate Treatment in the First Treatment Period
44.59
SECONDARY
Time to Non-persistence to Alendronate Treatment in the Second Treatment Period
42.76
SECONDARY
Overall Satisfaction to Study Treatment
3; 3; 1; 3; 17; 2
SECONDARY
Beliefs About Medicines Questionnaire (BMQ): Necessity Score
3.32; 3.26; 3.14; 3.31; 3.21; 3.17
SECONDARY
Beliefs About Medicines Questionnaire (BMQ) Concern Score
2.33; 2.43; 2.22; 2.12; 2.57; 2.51
SECONDARY
Beliefs About Medicines Questionnaire (BMQ) Preference Score
2.97; 3.47; 3.01; 3.72; 2.62; 3.43
SECONDARY
Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period
24.3; 24.4
SECONDARY
Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period
23.4; 23.8

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:
  • Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
  • Inability to stand or sit upright for at least 30 minutes.
  • 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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00518531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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