A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-07-31

Brief Summary

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A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

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Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOSAVANCE 5600

alendronate sodium (+) cholecalciferol

Group Type EXPERIMENTAL

FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)

Intervention Type DRUG

FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Calcium Supplement 500 mg

Intervention Type DIETARY_SUPPLEMENT

Calcium supplied locally by the investigator (containing 500 mg

calcium supplement) daily for 52 weeks (unless the patient's dietary intake of

calcium exceeds 1000 mg per day).

Referred-Care Model

Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.

Group Type OTHER

Referred-Care Model

Intervention Type OTHER

Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Interventions

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FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)

FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Intervention Type DRUG

Calcium Supplement 500 mg

Calcium supplied locally by the investigator (containing 500 mg

calcium supplement) daily for 52 weeks (unless the patient's dietary intake of

calcium exceeds 1000 mg per day).

Intervention Type DIETARY_SUPPLEMENT

Referred-Care Model

Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female
* 65 years or older
* Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score \<= -2.5 at spine or hip) or prior fragility fracture BMD T-score \<=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites
* Postmenopausal
* Low levels of vitamin D as measured 25-hydroxyvitamin D
* Has fallen at least once within the past 12 months