Official Title: “A Double-Blind, Randomized, Placebo-Controlled, Multicenter 4-Week Study to Assess the Effect of Alendronate 70 mg and Vitamin D3 2800 IU Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women”

To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: July 2005

Placebo will be administered over a 4 week, single-blind run-in phase. Calcium, as citrate-malate, will be administered throughout the study at an individualized dose supplementing the patient's daily dietary calcium intake to a total of approximately 1200 mg.

At the end of the stabilization period, baseline calcium absorption will be determined and patients will be randomized to receive either MK0217A, or matching placebo once weekly for 4 weeks.

Intervention(s) in this Clinical Trial

• Drug: alendronate sodium (+) cholecalciferol
  • MK0217A, a tablet containing alendronate 70-mg and vitamin D3 2800 IU, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.
• Drug: Comparator: Placebo (unspecified)
  • MK0217A, Pbo tablet, once weekly for 4 weeks. All patients will be instructed to take the tablet fasting upon arising for the day with 6 to 8 oz. of plain water (i.e., tap), wait at least one-half hour while continuing to fast and before the first food, beverage (except water), or other medication. All patients must eat before lying down.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • MK0217A
• Placebo Comparator: 2
  • Placebo

Primary Measures

• To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
  • Time Frame: 4 Weeks
    Safety Issue?: No

Inclusion Criteria:

• The patient is a postmenopausal osteoporotic female
• The patient is willing to limit direct sunlight exposure during the course of the study
• The patient must be ambulatory
• The patient has serum 25-hydroxyvitamin D =25 ng/mL

Exclusion Criteria:

• The patient is contraindicated to bisphosphonate therapy
• The patient has a vitamin D deficiency
• Patient will be excluded if their weight is above 85 kg
• The patient has a history of prior osteoporotic fracture
• The patient is currently or has received in the past treatment with effects on bone or calcium metabolism
• The patient has malabsorption syndrome
• The patient has active thyroid disease
• The patient has metabolic bone disease
• The patient had a myocardial infarction within 6 months of screening visit
• The patient has impaired renal function
• The patient is currently or has been a smoker in the last year

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00641771

Study ID Number: 2008_517

ClinicalTrials.gov Identifier: NCT00641771

Health Authority: United States: Food and Drug Administration