Trial Outcomes & Findings for Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329) (NCT NCT01437111)
NCT ID: NCT01437111
Last Updated: 2024-04-22
Results Overview
Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Week 26
Results posted on
2024-04-22
Participant Flow
Participant milestones
| Measure |
Fosamax Plus: All Participants
All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
Treated Participants
|
198
|
|
Overall Study
COMPLETED
|
182
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Fosamax Plus: All Participants
All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Not reported
|
5
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Baseline characteristics by cohort
| Measure |
Fosamax Plus: All Treated Participants
n=198 Participants
All participants who received at least one oral dose combination tablet of Fosamax Plus.
|
|---|---|
|
Age, Continuous
|
68.81 Years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26Population: Full Analysis Set (FAS) consisted of participants who received \>=1 dose of study drug; had \>=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve
Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.
Outcome measures
| Measure |
Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline
n=28 Participants
Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
|
Fosamax Plus: Other Osteoporosis Therapy at Baseline
n=64 Participants
Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
|
Fosamax Plus: Treatment Naive at Baseline
n=94 Participants
Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
|
Fosamax Plus: All Treated Participants
n=186 Participants
All participants who received at least one oral dose combination tablet of Fosamax Plus.
|
|---|---|---|---|---|
|
Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 26Population: Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve.
Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
Outcome measures
| Measure |
Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline
n=28 Participants
Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
|
Fosamax Plus: Other Osteoporosis Therapy at Baseline
n=62 Participants
Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
|
Fosamax Plus: Treatment Naive at Baseline
n=92 Participants
Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
|
Fosamax Plus: All Treated Participants
n=182 Participants
All participants who received at least one oral dose combination tablet of Fosamax Plus.
|
|---|---|---|---|---|
|
Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
|
-12.65 Percent change
Standard Deviation 56.94
|
-49.82 Percent change
Standard Deviation 35.08
|
-76.81 Percent change
Standard Deviation 20.33
|
-57.74 Percent change
Standard Deviation 40.34
|
Adverse Events
Fosamax Plus: All Treated Participants
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fosamax Plus: All Treated Participants
n=198 participants at risk
All participants who received at least one oral dose combination tablet of Fosamax Plus.
|
|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.51%
1/198 • Number of events 1 • Up to Week 26
Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.51%
1/198 • Number of events 1 • Up to Week 26
Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
|
|
Musculoskeletal and connective tissue disorders
Femur fracture
|
0.51%
1/198 • Number of events 1 • Up to Week 26
Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm, malignant stage, unspecified
|
0.51%
1/198 • Number of events 1 • Up to Week 26
Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
|
Other adverse events
| Measure |
Fosamax Plus: All Treated Participants
n=198 participants at risk
All participants who received at least one oral dose combination tablet of Fosamax Plus.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
5.1%
10/198 • Number of events 10 • Up to Week 26
Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to allow the Sponsor to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Investigators have also agreed that any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER