A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541658

2007008

Details and patient eligibility

About

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly 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 35 mg delayed release given weekly and 5 mg immediate release given daily.

Enrollment: 923 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 or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip 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 >32 kg/m
• 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: Triple Blind

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923 participants in 3 patient groups

5 mg Before Breakfast

Active Comparator group

Description:

5 mg / Immediate-release Risedronate (At Least 30 Minutes Before Breakfast)

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

35 mg After Breakfast

Experimental group

Description:

35 mg / Delayed-release Risedronate (Immediately Following Breakfast)

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

35 mg Before Breakfast

Experimental group

Description:

35 mg / Delayed-release Risedronate (At Least 30 Minutes Before Breakfast)

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate