Back to results4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
alendronate sodium (+) cholecalciferol
Comparator: Placebo (unspecified)
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
MK0217A
Placebo
Outcomes
Primary Outcome Measures
To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641771
Brief Title
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MK0217A
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
alendronate sodium (+) cholecalciferol
Other Intervention Name(s)
MK0217A
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo (unspecified)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare change in fractional calcium absorption following administration of MK0217A relative to matching placebo, in postmenopausal women with osteoporosis
Time Frame
4 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21448918
Citation
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 D(3) on fractional calcium absorption in a double-blind, randomized, placebo-controlled trial in postmenopausal osteoporotic women. J Bone Miner Res. 2011 Aug;26(8):1836-44. doi: 10.1002/jbmr.395.
Results Reference
result
Learn more about this trial
4-Week Study to Assess the Effect of Alendronate and Vitamin D3 Once Weekly on Fractional Calcium Absorption in Postmenopausal Osteoporotic Women (0217A-230)
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