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

NCT00641771 | Completed Phase 1

• 3 other identifiers: 0217A-230MK0217A-2302008_517
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

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

  4 Weeks

Study Arms (2)

1

EXPERIMENTAL

MK0217A

Drug: alendronate sodium (+) cholecalciferol

2

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo (unspecified)

Interventions

alendronate sodium (+) cholecalciferol DRUG

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.

Also known as: MK0217A

1

Comparator: Placebo (unspecified) DRUG

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.

2

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related 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 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.

  PMID: 21448918 RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

Alendronate; Cholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 24, 2008
• Study Start: May 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: February 2, 2022

Record last verified: 2022-02