A Study of Monthly Risedronate for Osteoporosis

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00247273

EFC6062 AND HMRF004M/3001

2005032

Details and patient eligibility

About

The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.

Full description

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Enrollment: 1,294 patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female: 50 years of age or older
• >5 years since last menses natural or surgical
• have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture

Exclusion criteria

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
• BMI (body mass index) >32 kg/m^2
• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
• hypocalcemia or hypercalcemia of any cause
• markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,294 participants in 2 patient groups

1

Active Comparator group

Description:

5 mg risedronate, once daily for 2 years

Treatment:

Drug: risedronate

Drug: risedronate

2

Experimental group

Description:

150 mg risedronate taken once a month for 2 years

Treatment:

Drug: risedronate

Drug: risedronate