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Bisphosphonate

PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

Phase 4
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Approved for 5 Other Conditions

Summary

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.

Eligible Conditions
  • Osteoporosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2008 Phase 4 trial • 716 Patients • NCT00545363
3%
Diarrhoea
3%
Nausea
3%
Arthralgia
2%
Urinary tract infection
2%
Back pain
2%
Nasopharyngitis
2%
Abdominal pain
1%
Cystitis
1%
Tachycardia
1%
Dyspepsia
1%
Pharyngitis
1%
Forearm fracture
1%
Fracture
1%
Blood glucose increased
1%
Pain in jaw
1%
Headache
1%
Calculus urinary
1%
Laryngeal pain
1%
Hypertension
1%
Vertigo
1%
Bronchitis
1%
Ligament sprain
1%
Myalgia
1%
Influenza
1%
Musculoskeletal pain
1%
Bone pain
1%
Arteriosclerosis
1%
Influenza like illness
1%
Gastrooesophageal reflux disease
1%
Pyrexia
1%
Herpes zoster
1%
Abdominal pain upper
1%
Gastritis
1%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
BMF Participants
No BMF Participants

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ibandronate OralExperimental Treatment1 Intervention
Participants will receive ibandronate 150 milligrams (mg) tablet once monthly
Group II: Ibandronate IVExperimental Treatment1 Intervention
Participants will receive ibandronate 3 mg IV once every 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibandronate
FDA approved

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,460 Previous Clinical Trials
1,097,353 Total Patients Enrolled
23 Trials studying Osteoporosis
18,383 Patients Enrolled for Osteoporosis
Clinical TrialsStudy ChairHoffmann-La Roche
2,230 Previous Clinical Trials
896,709 Total Patients Enrolled
21 Trials studying Osteoporosis
18,150 Patients Enrolled for Osteoporosis
~26 spots leftby Dec 2025
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