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| ID | Type | Description | Link |
|---|---|---|---|
| DAPS |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence B | 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). |
|
| Treatment Sequence A | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alendronate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence With Treatment in the First Treatment Period | 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. | Treatment period 1 (Month 1 to Month 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence With Treatment in the Second Treatment Period | 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. |
Not provided
Inclusion Criteria:
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21927922 | Background | Freemantle N, Satram-Hoang S, Tang ET, Kaur P, Macarios D, Siddhanti S, Borenstein J, Kendler DL; DAPS Investigators. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int. 2012 Jan;23(1):317-26. doi: 10.1007/s00198-011-1780-1. Epub 2011 Sep 17. | |
| 23676636 |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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First subject enrolled 03-Oct-07, last subject enrolled 25-Jun-08; First subject crossovered 22-May-08, last subject crossovered 25-Jun-09;
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| ID | Title | Description |
|---|---|---|
| FG000 | Alendronate in Period 1 Then Denosumab in Period 2 | 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). |
| FG001 | Denosumab in Period 1 Then Alendronate in 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
| ||||||||||||||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alendronate in Period 1 Then Denosumab in Period 2 | 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). |
| BG001 | Denosumab in Period 1 Then Alendronate in Period 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence With Treatment in the First Treatment Period | 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. | The full analysis set (FAS) includes all participants who were randomized. | Posted | Number | Participants | Treatment period 1 (Month 1 to Month 12) |
|
24 months
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Period 1: Alendronate | Participants received alendronate 70 mg orally once a week in year 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019386 | Alendronate |
| D000069448 | Denosumab |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
Not provided
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Not provided
|
| denosumab | Drug | 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 period 2 (Months 13 to 24) |
| Compliance With Treatment in the First Treatment Period | 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). | Treatment period 1 (Month 1 to Month 12) |
| Compliance With Treatment in the Second Treatment Period | 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). | Treatment period 2 (Month 13 to Month 24) |
| Persistence With Treatment in the First Treatment Period | 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. | Treatment period 1 (Month 1 to Month 12) |
| Persistence With Treatment in the Second Treatment Period | 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. | Treatment period 2 (Month 13 to Month 24) |
| Time to Non-adherence to Alendronate Treatment in the First Treatment Period | 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. | Treatment Period 1 (Month 1 to Month 12) |
| Time to Non-adherence to Alendronate Treatment in the Second Treatment Period | 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. | Treatment Period 2 (Month 13 to Month 24) |
| Time to Non-compliance to Alendronate Treatment in the First Treatment Period | 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. | Treatment period 1 (Month 1 to Month 12) |
| Time to Non-compliance to Alendronate Treatment in the Second Treatment Period | 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. | Treatment period 2 (Month 13 to Month 24) |
| Time to Non-persistence to Alendronate Treatment in the First Treatment Period | 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. | Treatment period 1 (Month 1 to Month 12) |
| Time to Non-persistence to Alendronate Treatment in the Second Treatment Period | 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. | Treatment period 2 (Month 13 to Month 24) |
| Overall Satisfaction to Study Treatment | 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". | End of treatment period 1 (Month 12) |
| Beliefs About Medicines Questionnaire (BMQ): Necessity Score | 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. | Baseline, Month 6, Month 12, Month 18 and Month 24 |
| Beliefs About Medicines Questionnaire (BMQ) Concern Score | 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. | Baseline and Month 6, Month 12, Month 18, and Month 24 |
| Beliefs About Medicines Questionnaire (BMQ) Preference Score | 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. | Baseline and Month 6, Month 12, Month 18, and Month 24 |
| Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period | 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. | Month 6, Month 12 (treatment period 1) |
| Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period | 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. | Month 18, Month 24 (treatment period 2) |
| Background |
| Kendler DL, Macarios D, Lillestol MJ, Moffett A, Satram-Hoang S, Huang J, Kaur P, Tang ET, Wagman RB, Horne R. Influence of patient perceptions and preferences for osteoporosis medication on adherence behavior in the Denosumab Adherence Preference Satisfaction study. Menopause. 2014 Jan;21(1):25-32. doi: 10.1097/GME.0b013e31828f5e5d. |
| 20827547 | Background | Kendler DL, McClung MR, Freemantle N, Lillestol M, Moffett AH, Borenstein J, Satram-Hoang S, Yang YC, Kaur P, Macarios D, Siddhanti S; DAPS Investigators. Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate. Osteoporos Int. 2011 Jun;22(6):1725-35. doi: 10.1007/s00198-010-1378-z. Epub 2010 Sep 9. |
| 31665314 | Derived | Kendler D, Chines A, Clark P, Ebeling PR, McClung M, Rhee Y, Huang S, Stad RK. Bone Mineral Density After Transitioning From Denosumab to Alendronate. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e255-64. doi: 10.1210/clinem/dgz095. |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Early crossover |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
Participants received alendronate 70 mg orally once a week for 1 year.
| OG001 | Denosumab | Participants received denosumab 60 mg subcutaneously every 6 months for 1 year. |
|
|
|
| Secondary | Adherence With Treatment in the Second Treatment Period | 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. | The cross-over analysis set includes all participants who crossed over to their treatment period 2 treatment. | Posted | Number | Participants | Treatment period 2 (Months 13 to 24) |
|
|
|
|
| Secondary | Compliance With Treatment in the First Treatment Period | 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). | Full analysis set | Posted | Number | Participants | Treatment period 1 (Month 1 to Month 12) |
|
|
|
|
| Secondary | Compliance With Treatment in the Second Treatment Period | 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). | Crossover set | Posted | Number | Participants | Treatment period 2 (Month 13 to Month 24) |
|
|
|
|
| Secondary | Persistence With Treatment in the First Treatment Period | 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. | Full analysis set | Posted | Number | Participants | Treatment period 1 (Month 1 to Month 12) |
|
|
|
|
| Secondary | Persistence With Treatment in the Second Treatment Period | 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. | Crossover set | Posted | Number | Participants | Treatment period 2 (Month 13 to Month 24) |
|
|
|
|
| Secondary | Time to Non-adherence to Alendronate Treatment in the First Treatment Period | 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. | Full analysis set | Posted | Mean | Standard Error | weeks | Treatment Period 1 (Month 1 to Month 12) |
|
|
|
| Secondary | Time to Non-adherence to Alendronate Treatment in the Second Treatment Period | 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. | Crossover set | Posted | Mean | Standard Error | weeks | Treatment Period 2 (Month 13 to Month 24) |
|
|
|
| Secondary | Time to Non-compliance to Alendronate Treatment in the First Treatment Period | 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. | Full analysis set | Posted | Mean | Standard Error | weeks | Treatment period 1 (Month 1 to Month 12) |
|
|
|
| Secondary | Time to Non-compliance to Alendronate Treatment in the Second Treatment Period | 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. | crossover set | Posted | Mean | Standard Error | weeks | Treatment period 2 (Month 13 to Month 24) |
|
|
|
| Secondary | Time to Non-persistence to Alendronate Treatment in the First Treatment Period | 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. | Full analysis set | Posted | Mean | Standard Error | weeks | Treatment period 1 (Month 1 to Month 12) |
|
|
|
| Secondary | Time to Non-persistence to Alendronate Treatment in the Second Treatment Period | 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. | Crossover set | Posted | Mean | Standard Error | weeks | Treatment period 2 (Month 13 to Month 24) |
|
|
|
| Secondary | Overall Satisfaction to Study Treatment | 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". | 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. | Posted | Number | Participants | End of treatment period 1 (Month 12) |
|
|
|
| Secondary | Beliefs About Medicines Questionnaire (BMQ): Necessity Score | 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. | Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Month 6, Month 12, Month 18 and Month 24 |
|
|
|
| Secondary | Beliefs About Medicines Questionnaire (BMQ) Concern Score | 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. | Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Beliefs About Medicines Questionnaire (BMQ) Preference Score | 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. | Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Month 6, Month 12, Month 18, and Month 24 |
|
|
|
| Secondary | Medication Adherence Rating Scale (MARS) to Alendronate in the First Treatment Period | 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. | Participants in the PRO analysis set with observed data; "n" indicates the number of patients with available data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Month 6, Month 12 (treatment period 1) |
|
|
|
| Secondary | Medication Adherence Rating Scale (MARS) to Alendronate in the Second Treatment Period | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Month 18, Month 24 (treatment period 2) |
|
|
|
| 5 |
| 118 |
| 24 |
| 118 |
| EG001 | Treatment Period 1: Denosumab | Participants received denosumab 60 mg subcutaneously every 6 months in year 1. | 4 | 125 | 31 | 125 |
| EG002 | Treatment Period 2: Alendronate | 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. | 4 | 110 | 21 | 110 |
| EG003 | Treatment Period 2: Denosumab | 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. | 4 | 106 | 13 | 106 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hernia pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pelvic mass | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
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.
| D001519 | Behavior |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Moderately satisfied |
|
| Quite satisfied |
|
| Very satisfied |
|
| Month 12 (n=103, 95) |
|
| Month 18 (n=98, 98) |
|
| Month 24 (n=91, 100) |
|
| Month 12 (n=103, 95) |
|
| Month 18 (n=98, 98) |
|
| Month 24 (n=91, 100) |
|
| Month 12 (n=103, 95) |
|
| Month 18 (n=98, 98) |
|
| Month 24 (n=91, 100) |
|