4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: alendronate sodium (+) cholecalciferol (Drug); Comparator: Placebo (unspecified) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
To compare change in fractional calcium absorption following administration of MK0217A
relative to matching placebo, in postmenopausal women with osteoporosis
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
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
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: May 2004
Last updated: December 24, 2014
|
