4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00641771
• Other study ID #: 0217A-230
• Secondary ID: MK0217A-2302008_
• Status: Completed
• Phase: Phase 1
• Start date: May 2004
• Est. completion date: August 2005

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Shapses SA, Kendler DL, Robson R, Hansen KE, Sherrell RM, Field MP, Woolf E, Berd Y, Mantz AM, Santora AC 2nd. Effect of alendronate and vitamin D3 on fractional calcium absorption in a double-blind, randomized, placebo-controlled trial in postmenopausal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis		4 Weeks