A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

Roche

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Placebo; Drug: ibandronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00148915

BON103593

Details and patient eligibility

About

The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.

Enrollment: 98 patients

Sex: Female

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with osteoporosis
• BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites

Exclusion criteria

• Have been treated with other bisphosphonates or using chronic steroids within the past 6 months
• Have a history of major upper gastrointestinal (GI) diseases or have severe kidney dysfunction
• Have a spine fracture (identified on X-ray)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

98 participants in 2 patient groups, including a placebo group

Ibandronate

Experimental group

Description:

Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.

Treatment:

Drug: ibandronate

Placebo

Placebo Comparator group

Description:

Participants will receive ibandronate matched placebo tablet orally once monthly for one year.

Treatment:

Drug: Placebo