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Denosumab Adherence Preference Satisfaction Study

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ClinicalTrials.gov Identifier: NCT00518531
Recruitment Status : Completed
First Posted : August 20, 2007
Results First Posted : January 7, 2014
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: alendronate
Drug: denosumab
Enrollment 250
Recruitment Details First subject enrolled 03-Oct-07, last subject enrolled 25-Jun-08; First subject crossovered 22-May-08, last subject crossovered 25-Jun-09;
Pre-assignment Details  
Arm/Group Title Alendronate in Period 1 Then Denosumab in Period 2 Denosumab in Period 1 Then Alendronate in Period 2
Hide Arm/Group Description Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2). Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
Period Title: Treatment Period 1
Started 124 126
Received Treatment 119 124
Completed 106 114 [1]
Not Completed 18 12
Reason Not Completed
Adverse Event             5             0
Lost to Follow-up             5             3
Physician Decision             1             0
Protocol Violation             2             0
Withdrawal by Subject             4             6
Early crossover             1             3
[1]
Participants who completed Treatment Period 1 may choose not to start Treatment Period 2
Period Title: Treatment Period 2
Started 106 115 [1]
Received Treatment 106 110
Completed 103 95
Not Completed 3 20
Reason Not Completed
Withdrawal by Subject             0             8
Complete out of scheduled visit window             1             2
Adverse Event             1             7
Protocol-specified criteria             0             1
Non-compliance             1             2
[1]
Participants can start Treatment Period 2 without completing Treatment Period 1.
Arm/Group Title Alendronate in Period 1 Then Denosumab in Period 2 Denosumab in Period 1 Then Alendronate in Period 2 Total
Hide Arm/Group Description Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2). Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2). Total of all reporting groups
Overall Number of Baseline Participants 124 126 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 124 participants 126 participants 250 participants
65.3  (7.7) 65.1  (7.6) 65.2  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 124 participants 126 participants 250 participants
Female
124
 100.0%
126
 100.0%
250
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 124 participants 126 participants 250 participants
White or Caucasian 119 115 234
Black or African American 2 2 4
Hispanic or Latino 1 6 7
Asian 1 3 4
Japanese 1 0 1
1.Primary Outcome
Title Adherence With Treatment in the First Treatment Period
Hide Description 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.
Time Frame Treatment period 1 (Month 1 to Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) includes all participants who were randomized.
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 124 126
Measure Type: Number
Unit of Measure: Participants
Yes 95 111
No 29 15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alendronate, Denosumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0259
Comments All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by center and prior osteoporotic fracture
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 10.5
Confidence Interval (2-Sided) 95%
1.3 to 19.7
Estimation Comments Positive values for absolute risk reduction favor denosumab.
2.Secondary Outcome
Title Adherence With Treatment in the Second Treatment Period
Hide Description 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.
Time Frame Treatment period 2 (Months 13 to 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The cross-over analysis set includes all participants who crossed over to their treatment period 2 treatment.
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 115 106
Measure Type: Number
Unit of Measure: Participants
Yes 73 98
No 42 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alendronate, Denosumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments All statistical hypothesis tests were conducted at the 0.05 significance level. No adjustment was employed for multiple comparisons.
Method Cochran-Mantel-Haenszel
Comments Stratified by center and prior osteoporotic fracture
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 30.9
Confidence Interval (2-Sided) 95%
20.6 to 41.3
Estimation Comments Positive values for absolute risk reduction favor denosumab.
3.Secondary Outcome
Title Compliance With Treatment in the First Treatment Period
Hide Description 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).
Time Frame Treatment period 1 (Month 1 to Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 124 126
Measure Type: Number
Unit of Measure: Participants
Yes 97 114
No 27 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alendronate, Denosumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0138
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by center and prior osteoporotic fracture.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 11.00
Confidence Interval (2-Sided) 95%
2.2 to 19.7
Estimation Comments Positive values for absolute risk reduction favor denosumab.
4.Secondary Outcome
Title Compliance With Treatment in the Second Treatment Period
Hide Description 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).
Time Frame Treatment period 2 (Month 13 to Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 115 106
Measure Type: Number
Unit of Measure: Participants
Yes 78 99
No 37 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alendronate, Denosumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by center and prior osteoporotic fracture.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.7
Confidence Interval (2-Sided) 95%
17.6 to 37.7
Estimation Comments Positive values for absolute risk reduction favor denosumab.
5.Secondary Outcome
Title Persistence With Treatment in the First Treatment Period
Hide Description 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 Frame Treatment period 1 (Month 1 to Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 124 126
Measure Type: Number
Unit of Measure: Participants
Yes 99 114
No 25 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alendronate, Denosumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0291
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by center and prior osteoporotic fracture.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
1.1 to 18.5
Estimation Comments Positive values for absolute risk reduction favor denosumab.
6.Secondary Outcome
Title Persistence With Treatment in the Second Treatment Period
Hide Description 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 Frame Treatment period 2 (Month 13 to Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 115 106
Measure Type: Number
Unit of Measure: Participants
Yes 82 103
No 33 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alendronate, Denosumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by center and prior osteoporotic fracture.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 27.4
Confidence Interval (2-Sided) 95%
18.1 to 36.7
Estimation Comments Positive values for absolute risk reduction favor denosumab.
7.Secondary Outcome
Title Time to Non-adherence to Alendronate Treatment in the First Treatment Period
Hide Description 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 Frame Treatment Period 1 (Month 1 to Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 124
Mean (Standard Error)
Unit of Measure: weeks
43.29  (1.46)
8.Secondary Outcome
Title Time to Non-adherence to Alendronate Treatment in the Second Treatment Period
Hide Description 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 Frame Treatment Period 2 (Month 13 to Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 115
Mean (Standard Error)
Unit of Measure: weeks
39.45  (1.89)
9.Secondary Outcome
Title Time to Non-compliance to Alendronate Treatment in the First Treatment Period
Hide Description 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 Frame Treatment period 1 (Month 1 to Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 124
Mean (Standard Error)
Unit of Measure: weeks
43.75  (1.42)
10.Secondary Outcome
Title Time to Non-compliance to Alendronate Treatment in the Second Treatment Period
Hide Description 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 Frame Treatment period 2 (Month 13 to Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
crossover set
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 115
Mean (Standard Error)
Unit of Measure: weeks
39.97  (1.87)
11.Secondary Outcome
Title Time to Non-persistence to Alendronate Treatment in the First Treatment Period
Hide Description 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 Frame Treatment period 1 (Month 1 to Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 124
Mean (Standard Error)
Unit of Measure: weeks
44.59  (1.35)
12.Secondary Outcome
Title Time to Non-persistence to Alendronate Treatment in the Second Treatment Period
Hide Description 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 Frame Treatment period 2 (Month 13 to Month 24)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Crossover set
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 115
Mean (Standard Error)
Unit of Measure: weeks
42.76  (1.69)
13.Secondary Outcome
Title Overall Satisfaction to Study Treatment
Hide Description 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".
Time Frame End of treatment period 1 (Month 12)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Patient Reported Outcomes (PRO) analysis set for each independent treatment period included patients in the FAS who received at least one dose of study drug and had at least one post-baseline assessment in the relevant treatment period. Analysis population includes patients with observed data for ≥1 question in the questionnaire.
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 114 121
Measure Type: Number
Unit of Measure: Participants
Not at all satisfied 3 3
A little satisfied 1 3
Moderately satisfied 17 2
Quite satisfied 34 18
Very satisfied 59 95
14.Secondary Outcome
Title Beliefs About Medicines Questionnaire (BMQ): Necessity Score
Hide Description

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.

Time Frame Baseline, Month 6, Month 12, Month 18 and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point.
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 115 121
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n=104, 117) 3.32  (0.52) 3.26  (0.48)
Month 6 (n=106, 114) 3.14  (0.53) 3.31  (0.60)
Month 12 (n=103, 95) 3.21  (0.51) 3.17  (0.52)
Month 18 (n=98, 98) 3.20  (0.53) 3.28  (0.55)
Month 24 (n=91, 100) 3.21  (0.62) 3.22  (0.58)
15.Secondary Outcome
Title Beliefs About Medicines Questionnaire (BMQ) Concern Score
Hide Description 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.
Time Frame Baseline and Month 6, Month 12, Month 18, and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point.
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 115 121
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n=104, 117) 2.33  (0.48) 2.43  (0.46)
Month 6 (n=106, 114) 2.22  (0.51) 2.12  (0.51)
Month 12 (n=103, 95) 2.57  (0.48) 2.51  (0.50)
Month 18 (n=98, 98) 2.43  (0.58) 2.24  (0.49)
Month 24 (n=91, 100) 2.39  (0.58) 2.18  (0.51)
16.Secondary Outcome
Title Beliefs About Medicines Questionnaire (BMQ) Preference Score
Hide Description 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.
Time Frame Baseline and Month 6, Month 12, Month 18, and Month 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point.
Arm/Group Title Alendronate Denosumab
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
Overall Number of Participants Analyzed 115 121
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (n=104, 117) 2.97  (0.40) 3.47  (0.43)
Month 6 (n=106, 114) 3.01  (0.53) 3.72  (0.47)
Month 12 (n=103, 95) 2.62  (0.50) 3.43  (0.45)
Month 18 (n=98, 98) 2.55  (0.56) 3.77  (0.47)
Month 24 (n=91, 100) 2.57  (0.65) 3.80  (0.52)
17.Secondary Outcome
Title Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period
Hide Description 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.
Time Frame Month 6, Month 12 (treatment period 1)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point.
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 115
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Month 6 (n=109) 24.3  (1.1)
Month 12 (n= 100) 24.4  (1.4)
18.Secondary Outcome
Title Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period
Hide Description 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.
Time Frame Month 18, Month 24 (treatment period 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants in the PRO analysis set with at least one post-baseline assessment in both periods and with observed data; "n" indicates the number of patients with available data at each time point.
Arm/Group Title Alendronate
Hide Arm/Group Description:
Participants received alendronate 70 mg orally once a week for 1 year.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Treatment period 2 Month 6 (n=98) 23.4  (2.0)
Treatment period 2 Month 12 (n= 90) 23.8  (1.4)
Time Frame 24 months
Adverse Event Reporting Description

In Treatment Period 1, one participant received both treatments and is counted in the denosumab group for safety analyses.

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

 
Arm/Group Title Treatment Period 1: Alendronate Treatment Period 1: Denosumab Treatment Period 2: Alendronate Treatment Period 2: Denosumab
Hide Arm/Group Description Participants received alendronate 70 mg orally once a week in year 1. Participants received denosumab 60 mg subcutaneously every 6 months in year 1. Participants who received denosumab 60 mg subcutaneously every 6 months in year 1 then received alendronate 70 mg orally once a week in year 2. Participants who received alendronate 70 mg orally once a week in year 1 then received denosumab 60 mg subcutaneously every 6 months in year 2.
All-Cause Mortality
Treatment Period 1: Alendronate Treatment Period 1: Denosumab Treatment Period 2: Alendronate Treatment Period 2: Denosumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Period 1: Alendronate Treatment Period 1: Denosumab Treatment Period 2: Alendronate Treatment Period 2: Denosumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/118 (4.24%)   4/125 (3.20%)   4/110 (3.64%)   4/106 (3.77%) 
Cardiac disorders         
Atrial fibrillation  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
Cardiac failure congestive  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
General disorders         
Chest pain  1  0/118 (0.00%)  1/125 (0.80%)  0/110 (0.00%)  0/106 (0.00%) 
Hernia pain  1  0/118 (0.00%)  0/125 (0.00%)  1/110 (0.91%)  0/106 (0.00%) 
Pain  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
Pelvic mass  1  0/118 (0.00%)  0/125 (0.00%)  0/110 (0.00%)  1/106 (0.94%) 
Infections and infestations         
Clostridium difficile colitis  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
Diverticulitis  1  0/118 (0.00%)  1/125 (0.80%)  0/110 (0.00%)  0/106 (0.00%) 
Injury, poisoning and procedural complications         
Pubis fracture  1  0/118 (0.00%)  0/125 (0.00%)  0/110 (0.00%)  1/106 (0.94%) 
Musculoskeletal and connective tissue disorders         
Fracture nonunion  1  0/118 (0.00%)  0/125 (0.00%)  1/110 (0.91%)  0/106 (0.00%) 
Joint contracture  1  0/118 (0.00%)  0/125 (0.00%)  1/110 (0.91%)  0/106 (0.00%) 
Lumbar spinal stenosis  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
Muscle spasms  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
Osteoarthritis  1  0/118 (0.00%)  2/125 (1.60%)  0/110 (0.00%)  1/106 (0.94%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  0/118 (0.00%)  0/125 (0.00%)  1/110 (0.91%)  0/106 (0.00%) 
Ovarian neoplasm  1  0/118 (0.00%)  0/125 (0.00%)  0/110 (0.00%)  1/106 (0.94%) 
Squamous cell carcinoma  1  1/118 (0.85%)  0/125 (0.00%)  0/110 (0.00%)  0/106 (0.00%) 
Nervous system disorders         
Cerebrovascular accident  1  0/118 (0.00%)  0/125 (0.00%)  0/110 (0.00%)  1/106 (0.94%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/118 (0.00%)  0/125 (0.00%)  0/110 (0.00%)  1/106 (0.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Period 1: Alendronate Treatment Period 1: Denosumab Treatment Period 2: Alendronate Treatment Period 2: Denosumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/118 (20.34%)   31/125 (24.80%)   21/110 (19.09%)   13/106 (12.26%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  8/118 (6.78%)  11/125 (8.80%)  7/110 (6.36%)  3/106 (2.83%) 
Back pain  1  10/118 (8.47%)  5/125 (4.00%)  3/110 (2.73%)  4/106 (3.77%) 
Pain in extremity  1  5/118 (4.24%)  9/125 (7.20%)  4/110 (3.64%)  5/106 (4.72%) 
Nervous system disorders         
Headache  1  7/118 (5.93%)  4/125 (3.20%)  3/110 (2.73%)  3/106 (2.83%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  6/118 (5.08%)  5/125 (4.00%)  5/110 (4.55%)  1/106 (0.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00518531     History of Changes
Other Study ID Numbers: 20060232
DAPS
First Submitted: August 16, 2007
First Posted: August 20, 2007
Results First Submitted: July 1, 2010
Results First Posted: January 7, 2014
Last Update Posted: March 15, 2017