Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

Warner Chilcott

Status and phase: Completed; Phase 3

Conditions: Other Osteoporosis

Treatments: Drug: Risedronate; Drug: Placebo tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619957

2001092 and 2001092 OL

Details and patient eligibility

About

Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

Enrollment: 285 patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented osteoporosis of the femoral neck and lumbar spine

Exclusion criteria

• BMI greater than or equal to 35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

285 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years

Treatment:

Drug: Placebo tablet

Risedronate

Experimental group

Description:

35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years

Treatment:

Drug: Risedronate