Status:
COMPLETED
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
Lead Sponsor:
Organon and Co
Conditions:
Osteoporosis
Eligibility:
FEMALE
50-80 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00641771
Start Date
May 1 2004
End Date
August 1 2005
Last Update
February 2 2022
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