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A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Placebo
ibandronate
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibandronate

Placebo

Arm Description

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

Participants received monthly oral placebo for 12 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.
Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.
Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.
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
Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.

Full Information

First Posted
October 16, 2007
Last Updated
April 5, 2016
Sponsor
Hoffmann-La Roche
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00545051
Brief Title
A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.
Official Title
A Randomized, Double-blind Study to Evaluate the Effect of Once Monthly Bonviva on Lumbar Bone Mineral Density in the Prevention of Glucocorticoid-induced Osteoporosis in Post-menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibandronate
Arm Type
Experimental
Arm Description
Participants received monthly oral ibandronate (150 milligrams [mg]) for 12 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received monthly oral placebo for 12 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
po monthly for 12 months
Intervention Type
Drug
Intervention Name(s)
ibandronate
Other Intervention Name(s)
Bonviva/Boniva
Intervention Description
150mg po monthly for 12 months
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Description
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.
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6
Description
Lumbar spine BMD was measured at Baseline and Month 6 using DXA. Percent change from Baseline to Month 6 was calculated using analysis of covariance.
Time Frame
Baseline and Month 6
Title
Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12
Description
Left total hip BMD was measured by DXA at Baseline, and Months 6 and 12. If there was prosthesis of left hip, the measurement of right total hip BMD was done by DXA. Percent change from Baseline to Months 6 and 12 was calculated using analysis of (co)variance for repeated measurements.
Time Frame
Baseline and Months 6 and 12
Title
Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12
Description
Serum C-terminal Telopeptide of Type 1 Collagen (sCTX), Serum Procollagen Type 1 N-terminal Propeptide (P1NP) and Serum Bone Tartrate-resistant Acid Phosphatase Isoform 5b (TRACP) are measures of bone resorption and are measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Months 1, 6 and 12 was calculated using analysis of covariance for repeated measurements.
Time Frame
Baseline and Months 1, 6 and 12
Title
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
Description
Worsening in BMD was defined as BMD T-score at any site less than or equal to (≤) - 2.5 standard deviations and/or worsening in BMD of at least 7% at any site.
Time Frame
Month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: post-menopausal women, 50-85 years of age; any inflammatory rheumatoid disease including polymyalgia rheumatica; receiving treatment with 5-15 mg/day of prednisolone. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
City
Helsinki
ZIP/Postal Code
00350
Country
Finland
City
Hyvinkää
ZIP/Postal Code
05800
Country
Finland
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
City
Jyvaeskylae
ZIP/Postal Code
10100
Country
Finland
City
Jyväskylä
ZIP/Postal Code
40100
Country
Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
City
Lahti
ZIP/Postal Code
15110
Country
Finland
City
Oulu
ZIP/Postal Code
90029
Country
Finland
City
Oulu
ZIP/Postal Code
90100
Country
Finland
City
Tampere
ZIP/Postal Code
33100
Country
Finland
City
Tampere
ZIP/Postal Code
33101
Country
Finland
City
Turku
ZIP/Postal Code
20100
Country
Finland
City
Vantaa
ZIP/Postal Code
01300
Country
Finland

12. IPD Sharing Statement

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A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

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