Osteoporosis
Conditions
Keywords
Osteoporosis, Postmenopausal
Brief summary
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 \[25(OH)D\].
Interventions
DRUGMK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
One combination tablet orally once a week
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year * Meets bone mineral density (BMD) criteria * Agree to discontinue any osteoporosis drug treatment for duration of study
Exclusion criteria
* Any contraindication to alendronate and vitamin D * Not ambulatory * Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A \>10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement * History of malignancy \<5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer * One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease * User of illicit recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence * Heavy consumer of alcohol or alcohol containing products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | Baseline and Week 26 | Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fosamax Plus: All Treated Participants All participants who received at least one oral dose combination tablet of Fosamax Plus. | 198 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Not reported | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Fosamax Plus: All Treated Participants |
|---|---|
| Age, Continuous | 68.81 Years STANDARD_DEVIATION 8.39 |
| Sex: Female, Male Female | 193 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 198 |
| serious Total, serious adverse events | 4 / 198 |
Outcome results
Primary
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
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline | Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | 1 Participants |
| Fosamax Plus: Other Osteoporosis Therapy at Baseline | Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | 3 Participants |
| Fosamax Plus: Treatment Naive at Baseline | Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | 1 Participants |
| Fosamax Plus: All Treated Participants | Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 | 5 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline | Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | -12.65 Percent change | Standard Deviation 56.94 |
| Fosamax Plus: Other Osteoporosis Therapy at Baseline | Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | -49.82 Percent change | Standard Deviation 35.08 |
| Fosamax Plus: Treatment Naive at Baseline | Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | -76.81 Percent change | Standard Deviation 20.33 |
| Fosamax Plus: All Treated Participants | Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 | -57.74 Percent change | Standard Deviation 40.34 |