Phase 3
N=250
Denosumab Adherence Preference Satisfaction Study
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00518531 ↗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
| Outcome | Result | p-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).
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.