Phase 3
Completed N=200
Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Source: ClinicalTrials.gov NCT01437111 ↗Enrolled (actual)
200
Serious AEs
2.0%
Results posted
Jan 2014
Primary outcomePrimary: Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 — 1; 3; 1; 5 Participants
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].
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 |
1; 3; 1; 5 | — |
| SECONDARY Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 |
-12.65; -49.82; -76.81; -57.74 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01437111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.