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Denosumab Adherence Preference Satisfaction Study
This study is ongoing, but not recruiting participants.
Study NCT00518531   Information provided by Amgen
First Received: August 16, 2007   Last Updated: September 24, 2009   History of Changes

August 16, 2007
September 24, 2009
September 2007
July 2010   (final data collection date for primary outcome measure)
Proportion of subjects adherent to treatment at the end of treatment period 1. [ Time Frame: One year ] [ Designated as safety issue: No ]
Proportion of subjects adherent to treatment at the end of treatment period 1.
Complete list of historical versions of study NCT00518531 on ClinicalTrials.gov Archive Site
  • Proportion of subjects adherent to treatment at the end of treatment period 2. [ Time Frame: Two year ] [ Designated as safety issue: No ]
  • Proportion of subjects compliant to treatment at the end of each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
  • Proportion of subjects persisting with treatment at the end of each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
  • Time to treatment non-adherence (weeks) with 70 mg alendronate QW in each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
  • Time to treatment non-compliance (weeks) with 70 mg alendronate QW in each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
  • Time to treatment non-persistence (weeks) with 70 mg alendronate QW in each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
  • Subject preference to treatment at the end of treatment period 2. [ Time Frame: Measured at the end of treatment period 2 (2 years) ] [ Designated as safety issue: No ]
  • Proportion of subjects satisfied with treatment at the end of each treatment period. [ Time Frame: Measured at the end of each treatment period (1 year & 2 years) ] [ Designated as safety issue: No ]
  • BMQ scores and MARS scores during each treatment period. [ Time Frame: Measured during each treatment period ] [ Designated as safety issue: No ]
  • Proportion of subjects adherent to treatment at the end of treatment period 2.
  • Proportion of subjects compliant to treatment at the end of each treatment period.
  • Proportion of subjects persisting with treatment at the end of each treatment period.
  • Time to treatment non-adherence (weeks) with 70 mg alendronate QW in each treatment period.
  • Time to treatment non-compliance (weeks) with 70 mg alendronate QW in each treatment period.
  • Time to treatment non-persistence (weeks) with 70 mg alendronate QW in each treatment period.
  • Subject preference to treatment at 18 months and at the end of treatment period 2.
  • Proportion of subjects satisfied with treatment at the end of each treatment period.
  • BMQ scores and MARS scores at six months and at teh end of each treatment period and changes in scores.
 
Denosumab Adherence Preference Satisfaction Study
A Multicenter, Randomized, Cross-Over, Open-label Study to Evaluate the Adherence, Preference, and Satisfaction of Denosumab and Alendronate in Postmenopausal Women With Low Bone Mineral Density

The primary objective is to evaluate the adherence of subjects to SC 60 mg denosumab Q6M treatment compared to oral 70 mg alendronate QW treatment at the end of treatment period 1 (12 months).

 
Phase III
Interventional
Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Osteoporosis
  • Drug: denosumab
  • Drug: alendronate
  • Other: 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).
  • Other: 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).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
250
November 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ambulatory postmenopausal women based on medical history
  • > or = 55 years of age at the start of screening
  • Screening 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 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 (<49.9nmol/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 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).
Female
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00518531
Global Development Leader, Amgen Inc.
20060232, DAPS
Amgen
 
Study Director: MD Amgen
Amgen
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP