A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211) (FACT)

Organon

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Dietary Supplement: Vitamin D; Drug: Alendronate placebo; Drug: Risedronate 35 mg; Drug: Risendronate placebo; Drug: Alendronate; Dietary Supplement: Elemental Calcium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092014

0217-211

2004_016 (Other Identifier)

Details and patient eligibility

About

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.

Enrollment: 1,053 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with postmenopausal osteoporosis

Exclusion criteria

• Bilateral hip replacements
• Esophageal abnormalities
• Metabolic bone disease (example - Vitamin D deficiency)
• Medications that would affect the breakdown or build-up of bone turnover

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,053 participants in 2 patient groups

Alendronate 70 mg

Experimental group

Description:

Alendronate sodium, 70 mg, orally once weekly for up to 24 months

Treatment:

Dietary Supplement: Elemental Calcium

Drug: Risendronate placebo

Drug: Alendronate

Dietary Supplement: Vitamin D

Risendronate 35 mg

Active Comparator group

Description:

Risendronate, 35 mg, orally once weekly for up to 24 months

Treatment:

Dietary Supplement: Elemental Calcium

Drug: Risedronate 35 mg

Drug: Alendronate placebo

Dietary Supplement: Vitamin D