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

Roche logo

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

Trial contacts and locations

14

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems