Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Information source: Merck
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Merck
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].
Clinical Details
Official title: A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of participants with serum 25-hydroxyvitamin D greater than 50 ng/mL
Secondary outcome: Percent change from baseline on bone resorption marker of serum Beta-Cross Laps (β-CTX) at Week 26
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: November 2011
Last updated: November 11, 2011
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