NCT00545051

Brief Summary

This 2 arm study will investigate the efficacy and safety of Bonviva (150mg po monthly) in the prevention of glucocorticoid-induced osteoporosis in post-menopausal women. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, with vitamin D and calcium supplementation. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2006

Typical duration for phase_4

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
7 years until next milestone

Results Posted

Study results publicly available

May 12, 2016

Completed
Last Updated

May 12, 2016

Status Verified

April 1, 2016

Enrollment Period

3 years

First QC Date

October 16, 2007

Results QC Date

April 5, 2016

Last Update Submit

April 5, 2016

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12

    Lumbar spine BMD was measured at Baseline, and Months 6 and 12 using dual-energy x-ray absorptiometry (DXA). Percent change from Baseline to Month 12 was calculated using analysis of covariance.

    Baseline and Month 12

Secondary Outcomes (4)

  • Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6

    Baseline and Month 6

  • Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12

    Baseline and Months 6 and 12

  • Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12

    Baseline and Months 1, 6 and 12

  • Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months

    Month 6

Study Arms (2)

Ibandronate

EXPERIMENTAL

Participants received monthly oral ibandronate (150 milligrams \[mg\]) for 12 months.

Drug: ibandronate

Placebo

PLACEBO COMPARATOR

Participants received monthly oral placebo for 12 months.

Drug: Placebo

Interventions

PlaceboDRUG

po monthly for 12 months

Placebo
ibandronateDRUG

150mg po monthly for 12 months

Also known as: Bonviva/Boniva
Ibandronate

Eligibility Criteria

Age50 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post-menopausal women, 50-85 years of age;
  • any inflammatory rheumatoid disease including polymyalgia rheumatica;
  • receiving treatment with 5-15 mg/day of prednisolone.

You may not qualify if:

  • previous treatment with an iv bisphosphonate at any time;
  • previous treatment with an oral bisphosphonate within the last 6 months, \>1 month of treatment within last year, or \>3 months of treatment within last 2 years;
  • treatment with parathyroid hormone in last 2 years;
  • inability to stand or sit in an upright position for at least 60 minutes;
  • inability to swallow a tablet whole;
  • history of major gastrointestinal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Hämeenlinna, 13530, Finland

Location

Unknown Facility

Helsinki, 00100, Finland

Location

Unknown Facility

Helsinki, 00290, Finland

Location

Unknown Facility

Helsinki, 00350, Finland

Location

Unknown Facility

Hyvinkää, 05800, Finland

Location

Unknown Facility

Jyväskylä, 10100, Finland

Location

Unknown Facility

Jyväskylä, 40100, Finland

Location

Unknown Facility

Kuopio, 70211, Finland

Location

Unknown Facility

Lahti, 15110, Finland

Location

Unknown Facility

Oulu, 90029, Finland

Location

Unknown Facility

Oulu, 90100, Finland

Location

Unknown Facility

Tampere, 33100, Finland

Location

Unknown Facility

Tampere, 33101, Finland

Location

Unknown Facility

Turku, 20100, Finland

Location

Unknown Facility

Vantaa, 01300, Finland

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Results Point of Contact

Title
Medical Communications
Organization
Hoffmannb-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2007

First Posted

October 17, 2007

Study Start

May 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 12, 2016

Results First Posted

May 12, 2016

Record last verified: 2016-04

Locations

FI(15)