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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

Page last updated: December 08, 2011

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