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

Phase 3CompletedNCT00092014

Organon and Co1,053 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,053

Conditions

Postmenopausal Osteoporosis

Interventions

AlendronateDRUG

Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Risedronate 35 mgDRUG

Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Elemental CalciumDIETARY_SUPPLEMENT

Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

Eligibility

Sex: FEMALEMin age: 25 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months

Time frame: Baseline and 12 months

Mean percent change from baseline in hip trochanter BMD at 24 months

Time frame: Baseline and 24 months

Secondary Outcomes

Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months

Time frame: Baseline and 12 months

Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months

Time frame: Baseline and 24 months

Change from baseline in biochemical markers of bone turnover at 12 months

Time frame: Baseline and 12 months

Change from baseline in biochemical markers of bone turnover at 24 months

Time frame: Baseline and 24 months

Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months

Time frame: 12 months

Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months

Time frame: 24 months

Number of participants who experienced one or more adverse events (AE)

Time frame: Up to 24 months

Number of participants who discontinued study medication due to an AE

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.