Official Title: “A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Study the Efficacy and Safety of MK0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women”

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density, improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: alendronate sodium (+) cholecalciferol
  • (Alendronate Sodium 70 mg/Vitamin D 5600 I.U combination tablet) once weekly

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• No Intervention: 2
  • Referred-Care (usual treatment for osteoporosis chosen and prescribed by patients' own physician).

Primary Measures

• Test safety and tolerability of study drug and compare results, of vitamin D levels in the blood, in women using study drug versus women receiving standard care treatment.
  • Time Frame: 52 weeks
    Safety Issue?: Yes

Secondary Measures

• Measure biochemical markers that indicate osteoporosis in women using study drug versus women receiving standard care treatment.
  • Time Frame: 52 weeks
    Safety Issue?: No

Inclusion Criteria:

• Female; 65 years or older; diagnosed with osteoporosis
• Postmenopausal
• Low levels of vitamin D as measured 25(OH)D
• Has fallen at least once within the past 12 months

Exclusion Criteria:

• Unable to stand or sit upright for at least 30 minutes
• Has a bone disorder other than osteoporosis

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00692913

Study ID Number: 2007_653

ClinicalTrials.gov Identifier: NCT00692913

Health Authority: United States: Food and Drug Administration