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4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00641771
First received: March 18, 2008
Last updated: November 2, 2009
Last verified: November 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: alendronate sodium (+) cholecalciferol
Drug: Comparator: Placebo (unspecified)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2004
Study Completion Date: October 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MK0217A
 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.
Other Name: MK0217A
Placebo Comparator: 2
Placebo
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641771

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00641771     History of Changes
Other Study ID Numbers: 2008_517, MK0217A-230
Study First Received: March 18, 2008
Last Updated: November 2, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D
Vitamins
 Alendronate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 13, 2013