Denosumab Adherence Preference Satisfaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00518531
First received: August 16, 2007
Last updated: January 22, 2014
Last verified: January 2014

August 16, 2007
January 22, 2014
September 2007
June 2009   (final data collection date for primary outcome measure)
Adherence With Treatment in the First Treatment Period [ Time Frame: Treatment period 1 (Month 1 to Month 12) ] [ Designated as safety issue: No ]
A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.
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
  • Adherence With Treatment in the Second Treatment Period [ Time Frame: Treatment period 2 (Months 13 to 24) ] [ Designated as safety issue: No ]
    A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed nonadherent to treatment.
  • Compliance With Treatment in the First Treatment Period [ Time Frame: Treatment period 1 (Month 1 to Month 12) ] [ Designated as safety issue: No ]
    Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).
  • Compliance With Treatment in the Second Treatment Period [ Time Frame: Treatment period 2 (Month 13 to Month 24) ] [ Designated as safety issue: No ]
    Participants were considered compliant to denosumab treatment if they received 2 denosumab injections (overall treatment compliance) and if they took each injection 6 months (± 4 weeks) apart (treatment compliance over time). Participants were considered compliant to alendronate treatment if they took ≥ 80% QW tablets (overall treatment compliance).
  • Persistence With Treatment in the First Treatment Period [ Time Frame: Treatment period 1 (Month 1 to Month 12) ] [ Designated as safety issue: No ]
    Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.
  • Persistence With Treatment in the Second Treatment Period [ Time Frame: Treatment period 2 (Month 13 to Month 24) ] [ Designated as safety issue: No ]
    Denosumab-treated participants were considered persistent to treatment if they completed the relevant treatment period and alendronate-treated participants were considered persistent to treatment if they completed the relevant treatment period and took at least 2 tablets in the last month of the treatment period.
  • Time to Non-adherence to Alendronate Treatment in the First Treatment Period [ Time Frame: Treatment Period 1 (Month 1 to Month 12) ] [ Designated as safety issue: No ]
    Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.
  • Time to Non-adherence to Alendronate Treatment in the Second Treatment Period [ Time Frame: Treatment Period 2 (Month 13 to Month 24) ] [ Designated as safety issue: No ]
    Time to treatment non-adherence for alendronate is defined for each treatment period as the time to treatment non-compliance or time to treatment non-persistence, whichever occurs earliest, for participants with uncensored values. Participants who had both censored time to non-compliance and censored time to non-persistence values were censored in the analysis at the end of treatment period visit.
  • Time to Non-compliance to Alendronate Treatment in the First Treatment Period [ Time Frame: Treatment period 1 (Month 1 to Month 12) ] [ Designated as safety issue: No ]
    Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.
  • Time to Non-compliance to Alendronate Treatment in the Second Treatment Period [ Time Frame: Treatment period 2 (Month 13 to Month 24) ] [ Designated as safety issue: No ]
    Time to treatment non-compliance for alendronate is based on the percent of QW tablets taken and is defined for each treatment period as the first week since Study Day 1 of the treatment period to the week where the percent of QW tablets taken falls below the threshold of ≥ 80% and where the participant can not reach this threshold again during the treatment period.
  • Time to Non-persistence to Alendronate Treatment in the First Treatment Period [ Time Frame: Treatment period 1 (Month 1 to Month 12) ] [ Designated as safety issue: No ]
    Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.
  • Time to Non-persistence to Alendronate Treatment in the Second Treatment Period [ Time Frame: Treatment period 2 (Month 13 to Month 24) ] [ Designated as safety issue: No ]
    Time to non-persistence for alendronate is defined for each treatment period as the first time <2 tablets were taken in a rolling 4-week time period (e.g. study weeks 1-4, 2-5, 3-6 etc) and where the participant never reaches this threshold again during the treatment period. Tablet intake was tracked using a Medication Event Monitoring System.
  • Overall Satisfaction to Study Treatment [ Time Frame: End of treatment period 1 (Month 12) ] [ Designated as safety issue: No ]
    Participant satisfaction with their treatment was assessed using question 7 (ie, "Please rate your satisfaction with the weekly pill on the following: frequency of administration; mode of administration [taking a pill]; convenience; overall satisfaction") and question 8 (ie, "Please rate your satisfaction with the six month injection on the following: frequency of administration; mode of administration [receiving an injection]; convenience; overall satisfaction") from the Preference Satisfaction Questionnaire (PSQ) at the end of each treatment period. The PSQ is a 34 item, self-report questionnaire of participants' preference and satisfaction for each of the two study treatments. Possible answers include: "Not at all Satisfied", "A Little Satisfied", "Moderately Satisfied", "Quite Satisfied", and "Very Satisfied".
  • Beliefs About Medicines Questionnaire (BMQ): Necessity Score [ Time Frame: Baseline, Month 6, Month 12, Month 18 and Month 24 ] [ Designated as safety issue: No ]

    The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other.

    Participants' beliefs about the necessity of the prescribed medication to treat osteoporosis were based on the average of 5 items from the BMQ that form the necessity score. The necessity score ranges from 1 to 5, with higher scores indicating stronger beliefs about the necessity of the prescribed medication for controlling osteoporosis.

  • Beliefs About Medicines Questionnaire (BMQ) Concern Score [ Time Frame: Baseline and Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. Participants' concern about the adverse consequences of taking the medication for controlling osteoporosis was based on the average of 10 items from the BMQ that form the concern score. The concern score ranges from 1 to 5, with higher scores indicating stronger concerns about the adverse consequences of taking the prescribed medication for controlling osteoporosis.
  • Beliefs About Medicines Questionnaire (BMQ) Preference Score [ Time Frame: Baseline and Month 6, Month 12, Month 18, and Month 24 ] [ Designated as safety issue: No ]
    The BMQ is a 22- item self-reported questionnaire specific to osteoporosis that measures beliefs about the weekly pill or every 6 months injection. The BMQ consists of 3 subscales measuring beliefs about the necessity of the medication for controlling osteoporosis, concern with the adverse consequences of taking the medication, and preference for one medication over the other. The BMQ preference score, which measures a participant's overall evaluation of a medication, is based on the average of 7 items in the BMQ. The preference score ranges from 1 to 5, with higher scores indicating stronger preference for one medication over the other.
  • Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period [ Time Frame: Month 6, Month 12 (treatment period 1) ] [ Designated as safety issue: No ]
    The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.
  • Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period [ Time Frame: Month 18, Month 24 (treatment period 2) ] [ Designated as safety issue: No ]
    The MARs questionnaire is a validated, self-reported instrument for assessing treatment adherence. Participants report how often they engage in each of 5 aspects of non-adherent behavior (forgetting to take a dose, changing the dose, stop taking them for a while, deciding to not take a dose, or taking less than instructed). Scores are summed over the 5 items, the total score ranges from 5 to 25 with higher scores indicating greater self-reported adherence. The MARS was collected at the month 6 and month 12 visits of each treatment period only for those participants receiving oral alendronate during that period.
  • 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.
Not Provided
Not Provided
 
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 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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
  • Drug: alendronate
    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.
  • Drug: denosumab
    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.
  • Treatment Sequence B
    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).
    Interventions:
    • Drug: alendronate
    • Drug: denosumab
  • Treatment Sequence A
    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).
    Interventions:
    • Drug: alendronate
    • Drug: denosumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
June 2010
June 2009   (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 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).
Female
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00518531
20060232, DAPS
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2014

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