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

Organon

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol); Other: Referred-Care Model; Dietary Supplement: Calcium Supplement 500 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00692913

0217A-262

2007_653

Details and patient eligibility

About

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.

Enrollment: 515 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Unable to stand or sit upright for at least 30 minutes
• Has a bone disorder other than osteoporosis
• Contraindication to the use of FOSAVANCE

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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515 participants in 2 patient groups

FOSAVANCE 5600

Experimental group

Description:

alendronate sodium (+) cholecalciferol

Treatment:

Dietary Supplement: Calcium Supplement 500 mg

Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)

Referred-Care Model

Other group

Description:

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

Treatment:

Other: Referred-Care Model