Status:
COMPLETED
Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
Lead Sponsor:
Organon and Co
Conditions:
Osteoporosis
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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-hydroxyv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01437111
Start Date
October 26 2011
End Date
December 5 2012
Last Update
April 22 2024
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