Osteoporosis
Conditions
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 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.
Interventions
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.
DRUGComparator: 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.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 80 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis | 4 Weeks |
Outcome results
None listed