A Phase 3 interventional study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet in Osteoporosis, sponsored by Organon and Co. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].
1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.
This study's enrollment of 200 is above the median of 95 across 1,152 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants
Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
One combination tablet orally once a week
Also known as: Fosamax Plus 70/5600
Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.
Time frame: Week 26
Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
Time frame: Baseline and Week 26
| Milestone | Fosamax Plus: All Participants |
|---|---|
| Started | 200 |
| Treated participants | 198 |
| Completed | 182 |
| Not completed | 18 |
| Withdrew: Adverse event | 2 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Not reported | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Protocol violation | 1 |
Serum samples to measure serum 25-hydroxyvitamin D \[25(OH)D\] will be collected at specific visits during the treatment phase of the study.
| Participants | Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline | Fosamax Plus: Other Osteoporosis Therapy at Baseline | Fosamax Plus: Treatment Naive at Baseline | Fosamax Plus: All Treated Participants |
|---|---|---|---|---|
| Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | 1 | 3 | 1 | 5 |
Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
| Percent change | Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline | Fosamax Plus: Other Osteoporosis Therapy at Baseline | Fosamax Plus: Treatment Naive at Baseline | Fosamax Plus: All Treated Participants |
|---|---|---|---|---|
| Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | -12.65 ± 56.94 | -49.82 ± 35.08 | -76.81 ± 20.33 | -57.74 ± 40.34 |
Collected over Up to Week 26. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fosamax Plus: All Treated Participants | — | 4/198 (2%) | 10/198 (5.1%) |
| Event | Fosamax Plus: All Treated Participants |
|---|---|
| DyspepsiaGastrointestinal disorders | 1/198 |
| HyponatraemiaMetabolism and nutrition disorders | 1/198 |
| Femur fractureMusculoskeletal and connective tissue disorders | 1/198 |
| Tongue neoplasm, malignant stage, unspecifiedNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/198 |
| Event | Fosamax Plus: All Treated Participants |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 10/198 |
Baseline Analysis was performed on the All Patients as Treated (APaT) population, which included all participants who received treatment. Of 200 participants enrolled in the study, baseline data were not provided for two participants who did not receive treatment.
| Age, Continuous(Years) | Fosamax Plus: All Treated Participants |
|---|---|
| Mean | 68.81 ± 8.39 |
| Sex: Female, Male(Participants) | Fosamax Plus: All Treated Participants |
|---|---|
| Female | 193 |
| Male | 5 |
No study locations are listed for this record.
Plan to share: No
Ran from Oct 2011 to primary completion in Dec 2012, 13 months.
Results were first posted in Jan 2014, 1 year 1 month after primary completion.
Of 49 industry-sponsored phase 3 interventional studies under Osteoporosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 43. This study's 13 months is below that.
Counting every sponsor, half of 58 studies reached it within 26 months; a quarter within 19 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.